Category: Knowledge Base

Introduction

Compounded sermorelin peptide therapy is an innovative, off-label approach for adults seeking weight loss, especially those who cannot tolerate GLP-1 agonists such as semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro), or similar medications, or those of you who are not candidates for GLP-1 agonist therapy in the first place. Sermorelin is a man-made peptide that mimics the first 29 amino acids of the body’s natural growth hormone-releasing hormone (GHRH). Basically, there’s a hormone that tells your brain to release another hormone.

When administered subcutaneously (into the fat under the skin), sermorelin stimulates your pituitary gland (in the middle of your brain) to release endogenous growth hormone (GH) in a physiologically regulated, pulsatile manner. This natural stimulation of GH leads to increased production of insulin-like growth factor 1 (IGF-1) in your liver, which in turn drives many of the metabolic and anabolic effects associated with GH.

The scientific rationale for using sermorelin for weight loss is based on the well-established role of GH in promoting lipolysis (the breakdown of fat), reducing visceral adiposity (abdominal or belly fat), and preserving or increasing lean muscle mass. In those who are overweight or obese, GH secretion is often blunted, contributing to fat accumulation and overall metabolic dysfunction. By enhancing endogenous GH secretion, sermorelin may help counteract these effects, supporting healthier body composition and metabolic health. Unlike direct GH injections, sermorelin’s action is subject to your body’s natural feedback mechanisms, reducing the risk of excessive GH levels and associated side effects.

Although most clinical data on sermorelin come from its use in children with growth hormone deficiency, where it has been shown to be both safe and effective for promoting growth, the underlying mechanism is directly relevant to adults seeking weight loss. Preclinical studies and trials with related GHRH analogues in adults have demonstrated reductions in visceral fat, improvements in cardiovascular risk markers, and favorable changes in body composition, all without significant adverse effects on glucose metabolism or other safety concerns. This makes compounded sermorelin an attractive option for adults who are not candidates for, or cannot tolerate, GLP-1 agonists.

Why Sermorelin for Weight Loss?

Sermorelin offers a unique set of benefits for adults seeking weight loss, particularly those who have experienced intolerable side effects or limited access to GLP-1 agonists. Its mechanism of action, safety profile, and patient experience distinguish it from other commonly prescribed weight loss medications such as phentermine and orlistat.

Benefits over GLP-1 Agonists

GLP-1 agonists, including semaglutide, tirzepatide, Ozempic, Wegovy, Mounjaro, and Zepbound, are highly effective for weight loss but are frequently associated with gastrointestinal side effects such as nausea, vomiting, diarrhea, and abdominal pain. These symptoms are dose-dependent and often lead to discontinuation or intolerance in a significant proportion of patients. In general, patients who slowly increase their dose and do not delay injections tend to do well, without significant side effects. At most, these patients complain of 1-3 days of mild nausea after each injection. Others complain of upper abdominal discomfort that they attribute to acid reflux, which may be related to the pharmacologic effect of delayed gastric emptying. In addition, GLP-1 agonists can cause less common but serious side effects such as pancreatitis, gallbladder disease, and hypersensitivity reactions. These patients often end up in the ER with me and sometimes get admitted to the hospital for removal of the gallbladder or for IV fluids. The high cost and frequent insurance denials for these medications further limit their accessibility for many adults. 

In contrast, compounded sermorelin peptide therapy is not associated with gastrointestinal side effects, as it does not act on the gut or central appetite pathways. Instead, it works by stimulating the body’s own GH production, leading to increased fat breakdown and improved body composition without provoking nausea or digestive discomfort. Patient-reported experiences with compounded sermorelin consistently highlight its superior tolerability, with the most common side effects being mild and transient, such as injection site reactions and facial flushing. These positive experiences are especially valued by adults who have discontinued GLP-1 agonists due to intolerable side effects or who are unable to access these medications due to cost or insurance barriers.

Surveys of patients using compounded medications, including hormone therapies similar to sermorelin, reveal high satisfaction rates, with more than 95% of respondents expressing satisfaction with all aspects of their therapy except for cost. Patients report that compounded medications are equally good or better than previous therapies, and the ability to customize dosing and formulation enhances both satisfaction and adherence.

Benefits of Sermorelin Peptide over Phentermine and Orlistat

Phentermine and orlistat are two other widely prescribed oral weight loss medications in the United States. Phentermine is a sympathomimetic amine that suppresses appetite by increasing norepinephrine release in the brain. It is only approved for short-term use (up to 12 weeks) and produces a mean weight loss of approximately 4–6% of baseline body weight over six months, with more than 40% of patients achieving at least 5% weight loss. The combination of phentermine with topiramate yields even greater weight loss, with 8–10% reductions in body weight over one year. However, phentermine is associated with side effects such as dry mouth, insomnia, headache, and constipation, and is contraindicated in patients with cardiovascular disease, uncontrolled hypertension, glaucoma, or a history of substance use disorder.

Orlistat is a pancreatic lipase inhibitor that reduces dietary fat absorption by about 30%, leading to modest weight loss of 2.8–4.8% of baseline body weight over one year. Its use is limited by frequent gastrointestinal side effects, including flatulence and steatorrhea (fatty or oily diarrhea), which often lead to discontinuation. Orlistat may also cause malabsorption of fat-soluble vitamins, leading to costly supplementation.

Sermorelin stands out from phentermine and orlistat in several key ways. First, its mechanism of action is physiologically regulated, promoting fat loss and lean mass preservation without interfering with natural processes in the body. Second, its safety profile is favorable, with only mild and transient side effects reported in clinical studies. Third, sermorelin does not carry the cardiovascular risks associated with phentermine or the bothersome gastrointestinal effects of orlistat. Finally, compounded sermorelin can be customized to individual patient needs, offering flexibility in dosing and formulation that is not possible with standard oral medications.

The Advantages of Compounded Sermorelin Peptide

Obtaining sermorelin as a compounded medication offers several important advantages over standard commercial options, particularly for adults seeking weight loss who are not candidates for GLP-1 agonists. Compounded sermorelin is prepared by specialized pharmacies that can customize the dosage, concentration, and formulation to meet individual patient needs. 

One of the most significant benefits of compounded sermorelin is improved accessibility. Because sermorelin is not FDA-approved for weight loss and is not commercially available for this indication, local retail pharmacies generally do not stock it. Compounding pharmacies, regulated primarily by state boards of pharmacy, can prepare sermorelin in the exact dosage and formulation prescribed by the physician, ensuring that patients receive a product tailored to their specific needs. Mail-order and delivery services offered by compounding pharmacies further enhance accessibility, especially for patients in remote areas or those with mobility limitations.

Cost is another important consideration. While compounded medications are generally more expensive than generic versions of the same medication, they tend to be less expensive than brand name GLP-1 agonists, which can cost over $1,000 per month. Most people don’t realize that insurance companies rarely help cover the cost of these medications, even for morbidly obese individuals who stand to benefit greatly from GLP-1 agonists. This is despite frustrating attempts at prior authorizations and subsequent appeals, resulting only in delays. This leads to many patients searching for other options.

That being said, semaglutide or tirzepatide, in a compounded form, can be a cost-effective option for those who cannot tolerate brand name medications or those who may benefit from customized dosing plans. 

I often prescribe compounded sermorelin to overweight patients who do not meet BMI criteria for GLP-1 agonists. Rather than waiting for them to gain more weight before meeting criteria, it is generally more prudent to try something like compounded sermorelin peptide to kickstart their weight loss and fitness journey.

Regulatory and quality assurance standards for compounding pharmacies are designed to ensure product safety and consistency. Pharmacies that prepare compounded sermorelin must adhere to United States Pharmacopeia (USP) Chapter 797 standards for sterile compounding, which include requirements for facility design, environmental controls, personnel training, and end-product testing. Patients and providers should select compounding pharmacies that are accredited by recognized organizations and can provide documentation of their quality assurance programs. Despite oversight by state boards of pharmacy, not all compounded medications are created equally. Remember to review the Certificate of Analysis before choosing to introduce a compounded substance into your body.

Dosing Sermorelin Peptide

Effective use of compounded sermorelin for weight loss requires careful attention to dosing, administration, and monitoring protocols. While there are no formal guidelines for sermorelin use in adults for weight loss, recommendations can be extrapolated from established protocols for growth hormone deficiency and related therapies.

Dosing and Administration

Compounded sermorelin is typically administered as a subcutaneous injection once daily at bedtime, aligning with the body’s natural circadian rhythm of growth hormone secretion. We sometimes recommend a five-on two-off approach, where you inject every weekday and take a break on the weekends. The most relevant dosing data come from pediatric studies, where subcutaneous sermorelin is given at 30 micrograms per kilogram body weight once daily. In research studies, dosing is often individualized, with typical starting doses ranging from 100 to 500 micrograms subcutaneously once daily. The dose can be titrated upward based on clinical response, tolerability, and laboratory monitoring, with adjustments made every six weeks as needed.

Rotating injection sites is important to minimize local irritation and prevent lipodystrophy, which is when fat is not uniformly distributed in one area. Compounded sermorelin is usually supplied in multi-dose vials and reconstituted with bacteriostatic water. 

Outpatient Monitoring

It would be reasonable to check serum IGF-1 levels 6 weeks after starting therapy and every 6 months after that to ensure that they don’t get too high.

Regular assessment of body weight, body mass index (BMI), waist circumference, and metabolic profile (fasting glucose and lipid panels) is recommended every six months. Bone mineral density should be assessed by dual-energy X-ray absorptiometry (DXA) every 2-3 years, as growth hormone therapies can affect bone metabolism. Thyroid and adrenal function should be evaluated periodically, as GH therapy can unmask or exacerbate underlying endocrine disorders. Sermorelin peptide can also increase the effect of thyroid hormone replacement medications like levothyroxine. These considerations should be discussed with your primary care provider before and after initiating therapy.

Adverse effects of sermorelin are generally mild and reversible with dose reduction. The most common side effects are transient facial flushing and injection site pain. Serious adverse effects are rare, but keep an eye out for signs of leg swelling, joint pain, muscle aches, numbness, or changes to sleep patterns.

Is Sermorelin an option for me?

Ideal patients are motivated to pursue weight loss, able to adhere to a regimen of regular almost-daily subcutaneous injections, and free of contraindications to increased growth hormone activity, such as active cancer or uncontrolled diabetes. We also cannot prescribe it to professional athletes, as it is considered a performance-enhancing drug.

Other benefits of sermorelin include anti-aging properties, improvement of bone density, enhancement of exercise performance and recovery, increased energy, better sleep, nicer skin, improved focus and mental clarity, positive mood, and stronger libido.

In summary, compounded sermorelin peptide therapy is a promising, off-label option for adults seeking weight loss who cannot obtain or tolerate GLP-1 agonists. Its physiologically regulated mechanism of action, favorable safety profile, and customizable dosing make it an attractive alternative to phentermine and orlistat as well. The advantages of compounded medications—improved accessibility, customization, and patient satisfaction—further enhance its appeal. With careful patient selection and individualized dosing, compounded sermorelin can provide meaningful benefits for adults seeking a safe and effective weight loss solution.

Disclaimer

Remember that I’m a doctor, but I may not be your doctor. Please always defer to your own provider’s treatment plan and personalized approach to your health care.

References

1. Medications for Obesity: A Review. Gudzune KA, Kushner RF. JAMA. 2024;332(7):571-584. doi:10.1001/jama.2024.10816. Link: https://pubmed.ncbi.nlm.nih.gov/39037780/
2. Strategies to Help Patients Navigate High Prescription Drug Costs. Lalani HS, Hwang CS, Kesselheim AS, Rome BN. JAMA. 2024;332(20):1741-1749. doi:10.1001/jama.2024.17275. Link: https://pubmed.ncbi.nlm.nih.gov/39432312/
3. Sermorelin: A Review of Its Use in the Diagnosis and Treatment of Children With Idiopathic Growth Hormone Deficiency. Prakash A, Goa KL. BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy. 1999;12(2):139-57. doi:10.2165/00063030-199912020-00007. Link: https://pubmed.ncbi.nlm.nih.gov/18031173/
4. Evaluation and Treatment of Adult Growth Hormone Deficiency: An Endocrine Society Clinical Practice Guideline. Molitch ME, Clemmons DR, Malozowski S, Merriam GR, Vance ML. The Journal of Clinical Endocrinology and Metabolism. 2011;96(6):1587-609. doi:10.1210/jc.2011-0179. Link: https://academic.oup.com/jcem/article/96/6/1587/2833853
5. Hormonal Replacement in Hypopituitarism in Adults: An Endocrine Society Clinical Practice Guideline. Fleseriu M, Hashim IA, Karavitaki N, et al. The Journal of Clinical Endocrinology and Metabolism. 2016;101(11):3888-3921. doi:10.1210/jc.2016-2118. Link: https://academic.oup.com/jcem/article/101/11/3888/2764912
6. American Association of Clinical Endocrinologists and American College of Endocrinology Guidelines for Management of Growth Hormone Deficiency in Adults and Patients Transitioning From Pediatric to Adult Care. Yuen KCJ, Biller BMK, Radovick S, et al. Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists. 2019;25(11):1191-1232. doi:10.4158/GL-2019-0405. Link: https://pubmed.ncbi.nlm.nih.gov/31760824/

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Compounded Tirzepatide
Compounded Semaglutide
Sermorelin Peptide
NAD+ Injections
Testosterone Replacement Therapy
Hair Loss
Erectile Dysfunction

Tirzepatide is the first medication in a new drug class sometimes known as a twincretin, because it targets two hormone receptors that regulate insulin and metabolism. Although tirzepatide was initially developed to treat type 2 diabetes, it has demonstrated significant effects on weight loss and has been rapidly adopted under the brand names Mounjaro (for diabetes) and Zepbound (for obesity).

The high demand for these drugs has resulted in shortages, so many patients and providers have turned to compounded tirzepatide, created at specialty pharmacies. If you are considering your options, it is essential to understand how tirzepatide works and the differences between the FDA-approved and compounded versions of this medication.

What Is Tirzepatide Peptide?

Tirzepatide is a synthetic peptide that consists of 39 amino acids. Amino acids are the building blocks of proteins. Peptides are short amino acid chains. They serve many important bodily functions. In addition to being the foundation of all proteins, they are involved in the immune system, tissue repair, signal transmission between cells, and the regulation of cellular function.

Tirzepatide mimics the action of two natural hormones released by intestinal cells: glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). These hormones, known as incretins, are secreted after eating and play critical roles in regulating appetite, stimulating the release of insulin, and processing carbohydrates and fats.

Tirzepatide acts on both GLP-1 and GIP receptors, which increase insulin secretion, slow stomach emptying, decrease appetite, and improve glucose control.

Insulin, Glucagon, and Blood Sugar Control

Maintaining a healthy blood sugar balance depends on the coordination of insulin and glucagon. These two peptide hormones, secreted by the pancreas, regulate blood sugar by acting on various cells and tissues throughout the body.

Insulin

• Insulin signals cells to take up glucose from the blood and convert it to glycogen, a form of carbohydrate storage in the liver and skeletal muscle.
  • Glycogen is composed of chains of glucose molecules that can be rapidly broken down into glucose when the body requires energy.
• Insulin also stimulates the uptake of glucose by fat cells, which then synthesize fat from glucose for longer-term storage.
• Insulin lowers blood sugar.

Glucagon

• Glucagon, by contrast, is released when blood sugar is low. I
• Glucagon signals the liver to break down glycogen into glucose for energy.
• Glucagon also stimulates glucose production from non-carbohydrate sources such as amino acids, a process known as gluconeogenesis.
• Glucagon typically increases blood sugar.

How Does Tirzepatide Peptide Work?

Tirzepatide shifts the balance of insulin and glucagon toward greater insulin action and reduced glucagon release, leading to improved glucose control and decreased hunger.

Tirzepatide’s dual action sets it apart from medications like semaglutide (Wegovy or Ozempic):

GLP-1 activity

• Increases the number of pancreatic betal cells
• Stimulates insulin secretion by beta cells
• Increases insulin sensitivity
• Increases clearance of triglycerides (a type of cholesterol)
• Breaks up fats
• Delays stomach emptying
• Acts on the brain’s appetite centers to promote fullness

GIP activity

• Mainly acts on pancreas
• Decreases glucagon release by the pancreas
• Increases insulin release
• Promotes fat storage
• Supports the synthesis of glycogen

People with type 2 diabetes often have abnormally low levels of GIP, or their pancreatic cells do not respond normally to GIP to release an adequate amount of insulin with food intake. People with obesity often have elevated GIP levels, since dietary fat stimulates GIP secretion.

The combined action of tirzepatide makes it highly effective in lowering hemoglobin A1C in individuals with diabetes and supporting sustained weight loss in those with obesity.

Manufacturing Shortages Led to Compounded Tirzepatide

Although Mounjaro is FDA-approved for the management of type 2 diabetes, doctors also prescribe it “off-label” for weight loss. Off-label prescribing refers to the use of a medication for a purpose other than its original FDA-approved indication. Zepbound is the same drug, but it is FDA-approved for weight loss in people with obesity. Neither drug currently has a generic version.

Due to the high demand for the drugs, a shortage of tirzepatide began in 2022 and lasted until December 2024. During this period, the FDA added tirzepatide to its drug shortage list and worked with the manufacturer to increase production. Although the shortage has largely been resolved, occasional supply issues persist at some pharmacies.

When a drug is on the shortage list, state-licensed compounding pharmacies are permitted to prepare compounded drugs that closely match the FDA-approved product. The active ingredient remains the same, although a compounding pharmacy may add or remove non-essential ingredients.

Compounded medications may also be prepared to remove allergens, create a liquid form for patients who cannot swallow pills, or adjust the dose strength to meet a specific patient’s needs.

What Is Compounded Tirzepatide?

Compounded tirzepatide has the same active ingredient as the FDA-approved brands. In some cases, an additional ingredient, such as vitamin B12, may be added. Compounded tirzepatide is legal, widely available through state-licensed compounding pharmacies, and often less expensive than brand-name versions.

Is Compounded Tirzepatide the Same as the Brand?

While compounded tirzepatide contains the same active ingredient as Mounjaro and Zepbound, there are some important differences:

• FDA-approved tirzepatide undergoes rigorous clinical testing and quality control. Compounded tirzepatide is not FDA-approved because it has not undergone the same review process, despite containing the same active peptide.

• Compounding pharmacies may prepare tirzepatide in different concentrations or delivery forms (such as multi-dose vials instead of prefilled pens).

• Quality may vary depending on the pharmacy. Patients should always obtain compounded tirzepatide from reputable, state-licensed pharmacies.

• In October 2024, the tirzepatide shortage was resolved, which limited compounding to patient-specific needs.

Why Many Patients Choose Compounded Tirzepatide

Compounded tirzepatide remains an attractive option for many patients. Cost is a major driver, since Mounjaro and Zepbound can cost more than $1,000 per month without insurance coverage. For uninsured patients or those denied coverage, compounded tirzepatide may be significantly more affordable.

Others prefer compounded tirzepatide because compounding pharmacies may offer dosing flexibility or added ingredients such as vitamin B12. For these reasons, patients should consult with their providers and always choose a reputable, state-licensed compounding pharmacy.

Key Takeaways

• Tirzepatide is a novel twincretin therapy that improves glucose control and promotes weight loss.

• Compounded versions of tirzepatide were created to provide an option for patients during drug shortages. It contains the same active peptide as the brand versions.

• FDA-approved products (Mounjaro, Zepbound) are still considered the gold standard for safety and consistency.

• Patients considering compounded tirzepatide should only obtain it from licensed pharmacies and under close medical supervision.

Concluding Thoughts

Tirzepatide is the first medication in a new class of drugs that target both the GLP-1 and GIP pathways. It has dramatically improved the management of type 2 diabetes and obesity.

Compounded tirzepatide provides an effective alternative for some patients, especially during shortages or when cost is a concern.

Providers should guide patients through their options — whether FDA-approved brands, insurance assistance programs, or compounded formulations — to ensure that the benefits of tirzepatide are realized safely and effectively.

References

Fisman EZ, Tenenbaum A. The dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide: a novel cardiometabolic therapeutic prospect. Cardiovasc Diabetol. 2021;20(1):225. Published 2021 Nov 24. doi:10.1186/s12933-021-01412-5

Frias JP, Davies MJ, Rosenstock J, et al. Tirzepatide versus placebo or active comparators in patients with type 2 diabetes: a systematic review and meta-analysis. *Lancet Diabetes Endocrinol.* 2021;9(12):776-785. doi:10.1016/S2213-8587(21)00274-7. PMID: 34656237. Hamza M, Papamargaritis D, Davies MJ. Tirzepatide for overweight and obesity management. Expert Opin Pharmacother. 2025;26(1):31-49. doi:10.1080/14656566.2024.2436595

Gudeman J, Jozwiakowski M, Chollet J, Randell M. Potential risks of pharmacy compounding. Drugs R D. 2013;13(1):1-8. doi:10.1007/s40268-013-0005-9

Liu L, Shi H, Xie M, Sun Y, Nahata MC. Efficacy and safety of tirzepatide versus placebo in overweight or obese adults without diabetes: a systematic review and meta-analysis of randomized controlled trials. Int J Clin Pharm. 2024;46(6):1268-1280. doi:10.1007/s11096-024-01779-x

Nauck MA, Müller TD. Incretin hormones and type 2 diabetes. Diabetologia. 2023;66(10):1780-1795. doi:10.1007/s00125-023-05956-x

Qureshi N, Wesolowicz L, Stievater T, Lin AT. Sterile compounding: clinical, legal, and regulatory implications for patient safety. J Manag Care Spec Pharm. 2014;20(12):1183-1191. doi:10.18553/jmcp.2014.20.12.1183

Rosenstock J, Wysham C, Frías JP, et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021;398(10295):143-155. doi:10.1016/S0140-6736(21)01324-6Improves Beta-cell Function and Insulin Sensitivity in Type 2 Diabetes. J Clin Endocrinol Metab. 2021;106(2):388-396. doi:10.1210/clinem/dgaa863

Timko RJ. Applying Quality by Design Concepts to Pharmacy Compounding. Int J Pharm Compd. 2015;19(6):453-463.

U.S. Food and Drug Administration. FDA clarifies policies for compounders as the national GLP-1 supply begins to stabilize. Published 2024. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize. Accessed September 24, 2025.

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Compounded Tirzepatide
Compounded Semaglutide
Sermorelin Peptide
NAD+ Injections
Testosterone Replacement Therapy
Hair Loss
Erectile Dysfunction

Sermorelin is a synthetic peptide (group of amino acids) that mimics the action of growth hormone-releasing hormone (GHRH), a natural substance produced in the
brain. By stimulating the front of the pituitary gland, sermorelin increases the body’s own production of growth hormone (GH), which in turn raises levels of insulin-like
growth factor 1 (IGF-1). These hormones play a crucial role in regulating metabolism, body composition, and overall health.

Subcutaneous sermorelin is used off-label (without FDA approval) in adults for several purposes. The most common off-label uses include anti-aging and general wellness,
athletic performance enhancement, and, less frequently, the management of adult growth hormone deficiency.

For you, there is reason to believe it can improve vitality, increase lean body mass, reduce body fat, enhance sleep quality, and boost energy. The rationale for these uses is
based on the natural decline in growth hormone secretion with age, known as “somatopause,” and the hypothesis that restoring GH levels may counteract some of the
metabolic and physical changes associated with aging.

The New England Journal of Medicine emphasizes that there is no compelling evidence from controlled studies that growth hormone therapy, including GHRH analogues like
sermorelin, provides meaningful benefits in healthy adults without a confirmed diagnosis of GHD.

What does that mean?

It is important to realize that high-quality randomized controlled trials are hard to come by. They are easy to do for a new medication, where they give one group a placebo and
compare blood glucose numbers with the group that got the novel medication. It is much more difficult to quantify sleep quality and energy levels. People don’t like filling
out surveys, so scientists often end up with fewer data points and unreliable results.

I want you to know that we recommend omega-3 fatty acids for mood, cognition, and inflammation, without robust data. We are almost certain that something like curcumin helps with arthritis and inflammatory bowel disease, but there are no high-quality trials to prove this. Most doctors, including me, agree that CoQ10 helps long-term for patients with heart failure or family history of dementia, but there are no meta-analyses to prove this either.

The strongest clinical evidence for the health benefits of GHRH analogues in adults comes from studies of tesamorelin, a peptide closely related to sermorelin. In a
randomized, double-blind, placebo-controlled trial published in The Journal of Clinical Endocrinology and Metabolism, daily subcutaneous administration of tesamorelin (2
mg once daily) in abdominally obese adults with reduced GH secretion resulted in a statistically significant reduction in visceral adipose tissue (VAT), improvement in
carotid intima-media thickness (cIMT), reduction in serum triglycerides, and lower C-reactive protein (CRP) levels compared to placebo over 12 months.

If you’re a nerd like me, this deep dive into the above study is for you. VAT decreased by 35 cm² (95% CI: -58, -12; P = 0.003), cIMT improved by 0.04 mm (95% CI: -0.07,
-0.01; P = 0.02), CRP decreased by 0.15 mg/L (95% CI: -0.30, -0.01; P = 0.04), and triglycerides dropped by 37 mg/dL (95% CI: -67, -7; P = 0.02). IGF-1 levels increased by
92 μg/L (95% CI: +52, +132; P < 0.0001).

While tesamorelin is not identical to sermorelin, both are GHRH analogues with similar mechanisms of action. These findings suggest that subcutaneous administration of a
GHRH analogue in adults can reduce visceral fat and improve certain cardiovascular risk factors, without adversely affecting glucose metabolism.

In a smaller, single-blind, randomized, placebo-controlled trial of nightly subcutaneous sermorelin in older adults (ages 55–71), administration of 10 micrograms per kilogram
body weight for 16 weeks resulted in significant increases in nocturnal GH and IGF-1 levels, increased skin thickness in both men and women, and increased lean body mass
and insulin sensitivity in men. Quality of life parameters showed improvement in general well-being and libido in men, but not in women, and sleep quality was unaffected. The only adverse event noted was transient hyperlipidemia, which resolved by the end of the study.

Subcutaneous administration is preferred, with injections given at bedtime to optimize physiological response. The injection site should be rotated to minimize local reactions.

The main absolute contraindication for sermorelin therapy in adults is the presence of an active cancer. Increased GH and IGF-1 levels may theoretically promote tumor
growth or recurrence, and adults with any active cancer—including solid tumors, hematologic cancers, or pituitary neoplasms—should not receive sermorelin. Soft
contraindications include diabetes, untreated thyroid or adrenal issues, benign intracranial hypertension, and diseases of the retina. We can’t approve it for
professional athletes, as it is on WADA’s list of performance-enhancing drugs.

Subcutaneous sermorelin is generally well tolerated in adults, with the most common side effects being mild and transient. Local reactions at the injection site, such as pain,
erythema, and transient facial flushing, are frequently observed and usually resolve without intervention. Systemic side effects are infrequent but may include mild
symptoms such as headache, nausea, and dizziness. In the adult trial by Khorram et al, the only adverse event noted was transient hyperlipidemia (basically cholesterol), which resolved by the end of the study. There were no serious or persistent local reactions, and no cases of impaired glucose tolerance or diabetes were reported.

Unlike recombinant GH, sermorelin has not been associated with significant fluid retention, peripheral edema, arthralgia, myalgia, carpal tunnel syndrome, or sleep
apnea in the available adult studies. The safety profile of sermorelin may be more favorable than that of rhGH, particularly with respect to fluid retention and metabolic
complications, but direct comparative data are not available.

Long-term safety data for sermorelin in adults are lacking. Large cohort studies of rhGH replacement in adults, such as the KIMS study, have shown that appropriate GH
therapy does not increase the risk of cancer, cardiovascular events, or diabetes when used in selected patients and dosed to maintain IGF-1 within the normal range.

I often recommend sermorelin to my patients who do not meet criteria for GLP-1 agonist medications, in order to improve the muscle-to-fat ratio. As long as you don’t
have cancer and are not a professional athlete, it is a generally well-tolerated and safe option.

1. Sermorelin: A Review of Its Use in the Diagnosis and Treatment of Children With Idiopathic
   Growth Hormone Deficiency.
   Prakash A, Goa KL.
   BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy.
   1999;12(2):139-57. doi:10.2165/00063030-199912020-00007.
   Link: https://pubmed.ncbi.nlm.nih.gov/18031173/

2. Hormonal Replacement in Hypopituitarism in Adults: An Endocrine Society Clinical Practice
   Guideline.
   Fleseriu M, Hashim IA, Karavitaki N, et al.
   The Journal of Clinical Endocrinology and Metabolism. 2016;101(11):3888-3921.
   doi:10.1210/jc.2016-2118.
   Link: https://academic.oup.com/jcem/article/101/11/3888/2764912
3. American Association of Clinical Endocrinologists and American College of Endocrinology
   Guidelines for Management of Growth Hormone Deficiency in Adults and Patients Transitioning
   From Pediatric to Adult Care.
   Yuen KCJ, Biller BMK, Radovick S, et al.
   Endocrine Practice : Official Journal of the American College of Endocrinology and the
   American Association of Clinical Endocrinologists. 2019;25(11):1191-1232.
   doi:10.4158/GL-2019-0405.
   Link: https://pubmed.ncbi.nlm.nih.gov/31760824/
4. Pathogenesis and Diagnosis of Growth Hormone Deficiency in Adults.
   Melmed S.
   The New England Journal of Medicine. 2019;380(26):2551-2562. doi:10.1056/NEJMra1817346.
   Link: https://pubmed.ncbi.nlm.nih.gov/31242363/
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