Peps
What is Setmelanotide?
Setmelanotide is a melanocortin-4 receptor agonist studied in rare genetic forms of obesity. The featured trials enrolled people with POMC or LEPR deficiency, rather than general-population obesity.
Biological role or research focus
Rare genetic obesity.
This was not a full-year parallel placebo-controlled comparison. Small, genetically selected cohorts do not establish effectiveness in common obesity.
Names you may encounter
RM-493
Search terms can include brands, combinations, or historical names. They are not automatic product equivalents.
- Class / identity
- Melanocortin-4 receptor agonist peptide
- Research focus
- Rare genetic obesity
- Featured evidence
- Human open-label phase 3 studies with withdrawal periods
- Source check
- October 4, 2026
Biology & proposed mechanism
MC4-receptor stimulation was tested in defined upstream genetic signaling disorders. A genetic-disease indication cannot be inferred for everyone with excess weight.
Medicine status & clinical context
The March 2026 U.S. Imcivree label includes acquired hypothalamic obesity from age four and specified Bardet-Biedl, POMC, PCSK1, or LEPR-related obesity from age two, with condition-specific diagnostic requirements. General polygenic obesity is outside these labeled indications. The early rare-genetic-obesity trials on this page do not cover every population in the updated label.
The selected trials concern severe early-onset genetic obesity. Current eligibility and medicine precautions require product-specific clinical references.
Source: DailyMed · Imcivree prescribing information · March 2026 indications ↗
What does the evidence show?
Selected published evidence, with the population, findings, and limits kept together. These original summaries draw on publication abstracts; they are not a systematic review.
Human open-label phase 3 studies with withdrawal periods · 2020
Setmelanotide in POMC or LEPR deficiency
What did this publication test, and what did it find?
- Population / model
- 10 participants with POMC deficiency and 11 with LEPR deficiency, aged six years or older.
- Study design
- Open-label phase 3 studies with approximately one-year outcomes and blinded withdrawal periods for responders.
- Main finding
- At least 10% weight loss was reported in 8 of 10 POMC participants and 5 of 11 LEPR participants.
- Limits & context
- This was not a full-year parallel placebo-controlled comparison. Small, genetically selected cohorts do not establish effectiveness in common obesity.
Read the original paper for methods, adverse events, funding, and conflicts of interest. Publisher access may require a subscription.
Further reading · 4 additional publication links
Exact-name PubMed search checked 2026-10-04. These records have not been appraised. A name match can include related compounds, combinations, or other formulations; it does not establish safety or benefit.
Current Treatments for Patients with Genetic Obesity. ↗
Journal of clinical research in pediatric endocrinology · 2023 May 29 · Review, Journal Article
Read available full text ↗
Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period. ↗
The lancet. Diabetes & endocrinology · 2022 Dec · Randomized Controlled Trial, Multicenter Study, Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't
Read available full text ↗
Evaluation of a melanocortin-4 receptor (MC4R) agonist (Setmelanotide) in MC4R deficiency. ↗
Molecular metabolism · 2017 Oct · Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't
Read available full text ↗
Pharmacotherapy for Obesity: Recent Updates. ↗
Clinical pharmacology : advances and applications · 2025 · Journal Article, Review
Read available full text ↗
New editorial updates
New source discoveries
Links appear automatically. Unreviewed discoveries are not verified medical findings.
Safety & precautions
Safety & what remains unknown
Reported effects included injection-site reactions, pigmentation changes, and nausea. The small cohorts cannot exclude uncommon harms.
Evidence boundaries
This was not a full-year parallel placebo-controlled comparison. Small, genetically selected cohorts do not establish effectiveness in common obesity.
Official product context · checked October 4, 2026
The label includes warnings about depression or suicidal thoughts, sexual-arousal effects, and serious hypersensitivity. Current eligibility and precautions should be read in the complete product label rather than inferred from a receptor mechanism.
Source: DailyMed · Imcivree prescribing information · March 2026 indications ↗
This is not a complete list of contraindications, interactions, or adverse effects. Medicine labels apply to specific products and indications; research-use listings are not interchangeable with approved medicines.
What are people discussing?
No editorial transcript note has been reviewed for this profile yet. Below are the matching video records available for exploration; title and caption matches are not verified claims.
Watch the source discussions
0 matching video records · 0 with captions indexed.
Across the full library, 30 caption files are indexed from 20,199 inventoried videos. Most transcripts remain unreviewed. Select a thumbnail or timestamp to watch inside PepsRadar. Thumbnail images load from YouTube.
No matching video has been identified in the current snapshot.
Sources & supplier listings
Listings are grouped by the vendor’s stated identity. Blends and modified derivatives are labeled separately. Inclusion is not a quality assessment or an endorsement.
We have not added a supplier for this profile. Missing products and coded listings are not filled with guesses.
Catalog checked 2026-10-04. Seller listings retain their stated intended use. Shops covered: BioLongevity Labs, BioLongevity Supplements, American Peptides, PSPeptides. This is not a market-wide comparison. Affiliate participation does not determine evidence or editorial coverage.
Questions worth asking
- Do these trials establish effectiveness for common obesity?
- What material, population, and route were actually studied?
- This was not a full-year parallel placebo-controlled comparison. Small, genetically selected cohorts do not establish effectiveness in common obesity.
- What adverse effects, uncertainty, and conflicts of interest does the original source report?
Frequently asked questions
Do these trials establish effectiveness for common obesity?
No. Their participants had defined rare genetic deficiencies; clinical eligibility depends on the exact condition and current product references.
Does the publication verify a supplier’s product?
No. The tested material and a commercial listing need separate identity and batch checks. A research-use disclaimer does not establish clinical suitability.
Does the official medicine reference cover every use discussed online?
No. The reference covers defined products and clinical settings. Research outside those uses needs separate evidence and does not extend the medicine’s authorization.
Source: DailyMed · Imcivree prescribing information · March 2026 indications ↗
References & editorial record
Source notes checked 2026-10-04. Original PepsRadar summaries. Not reviewed by a medical professional. Topic grouping is editorial navigation, not a treatment recommendation. Video notes specify which excerpts were reviewed; no full transcripts are published.