Setmelanotide
Targets the brain's melanocortin-4 appetite pathway, which is broken in some rare genetic forms of obesity.
FDA-approved as Imcivree for specific genetic obesity disorders.
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FDA-approved (Imcivree) for specific genetic obesity syndromes.
Daily price tracking started October 7, 2026; a price-history chart appears here once a few days have been collected.
| Vendor | Trust | Listing | Vials | Price | Per mg | |
|---|---|---|---|---|---|---|
Polaris Peptides #20 by metascore · US? |
Metascore 84Finnrick 63%Bought vials 110% of label · 99 testsTitrateLab · PeptideBase · PeptideCheckedNo report for thisOnline checkout |
Setmelanotide 10mg | 1 × 10 mg | $60.00 | $6.00 | Buy |
Mixing a 10 mg vial
What each common amount of bacteriostatic water gives you on a U-100 insulin syringe. Pick a vial size above to change it.
| Water | Strength | Per 10 units (0.1 mL) | Per unit |
|---|---|---|---|
| 1 mL | 10 mg/mL | 1,000 mcg | 100 mcg |
| 2 mL | 5 mg/mL | 500 mcg | 50 mcg |
| 3 mL | 3.333 mg/mL | 333.3 mcg | 33.33 mcg |
| 5 mL | 2 mg/mL | 200 mcg | 20 mcg |
Doses studied in research Approved drug
What was given to people (or animals) in published studies and official labels, each linked to its source. This is not a recommendation: study products, purity and supervision differ from research-grade vials.
Starting dosage 0.5 mg once daily for 2 weeks (acquired hypothalamic obesity, age 4+), 2 mg once daily for 2 weeks (BBS or POMC/PCSK1/LEPR deficiency, age 12+), 1 mg (age 6 to <12) or 0.5 mg (age 2 to <6), then titrated per label tables; maintenance 3 mg once daily for patients aged 6 and older, weight-based for younger children (subcutaneous)
Official label| Who was studied | Dose given | How often | For how long | What happened | |
|---|---|---|---|---|---|
| people aged 4-66 with acquired hypothalamic obesity (phase 3, randomised 2:1 vs placebo) n = 120 |
1.5 to 3.0 mg subcutaneous | once daily | 52 weeks after dose escalation | BMI change -16.5% vs +3.3% with placebo; greater reduction in hunger score | PubMed |
| patients aged 6+ with Bardet-Biedl or Alström syndrome and obesity (phase 3) n = 38 |
up to 3.0 mg subcutaneous | once daily | 14 weeks double-blind vs placebo, then 52 weeks open-label | 32.3% of BBS patients aged 12+ lost at least 10% of body weight at 52 weeks; skin hyperpigmentation in 61%, injection-site erythema 48% | PubMed |
| patients aged 6-40 with hypothalamic obesity (phase 2, open-label) n = 18 |
titrated up to 3.0 mg subcutaneous | once daily | 16 weeks | 89% had at least 5% BMI reduction; mean BMI reduction 15% | PubMed |
| children aged 2-5 with POMC/LEPR deficiency or BBS (phase 3 VENTURE, open-label) n = 12 |
starting 0.5 mg, increased every 2 weeks in 0.5 mg steps to a weight-based maximum subcutaneous | once daily | 52 weeks | 83% reached a BMI Z-score decrease of at least 0.2 | PubMed |
Studied and approved only for specific rare genetic or hypothalamic forms of obesity, not common obesity.
What the research says
Setmelanotide (an MC4R agonist) has human evidence only in rare genetic or hypothalamic forms of obesity: one 120-person phase 3 RCT in acquired hypothalamic obesity, one small RCT in Bardet-Biedl/Alström syndrome, and several small open-label trials, all showing meaningful BMI and hunger reductions; it has not been shown to work in common obesity, and skin darkening, nausea and injection-site reactions are frequent. Added real-world and registry-comparison data in Bardet-Biedl syndrome and related conditions (small, uncontrolled or externally controlled) are consistent with the trials.
Key papers ✓ 7~ 3
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Setmelanotide for the Treatment of Acquired Hypothalamic Obesity.Humans120 peopleRandomizedPlacebo-controlled52 weeksPhase 3 randomized (2:1) placebo-controlled trial (TRANSCEND)
In 120 people aged 4-66 with acquired hypothalamic obesity, 52 weeks of setmelanotide changed BMI by -16.5% vs +3.3% with placebo and reduced hunger; serious adverse events 28% vs 8%.
Key resultLSM BMI change -16.5% (95% CI -19.3 to -13.8) with setmelanotide vs 3.3% (95% CI -0.6 to 7.2) with placebo (P<0.001); serious adverse events 28% vs 8%
Study details
- Studied
- People aged 4 to 66 with acquired hypothalamic obesity
- Compared with
- Placebo
- Main outcome
- Mean percent change in BMI at 52 weeks
- Sample
- 120 participants (81 setmelanotide, 39 placebo)
- Authors' conclusion
- Setmelanotide significantly reduced BMI and hunger versus placebo at 52 weeks in participants aged 4 to 66 with acquired hypothalamic obesity.
- Limitations
- Adverse events in 100% of setmelanotide vs 90% of placebo participants.
-
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.Humans38 peopleRandomizedPlacebo-controlledDouble-blind14 weeks double-blind plus 52 weeks open-labelMulticentre randomised double-blind placebo-controlled phase 3 trial with open-label period
In 38 patients, 32.3% of those 12+ with Bardet-Biedl syndrome lost at least 10% of body weight after 52 weeks, but results in Alström syndrome were inconclusive; skin hyperpigmentation in 61%.
Key result32·3% (95% CI 16·7 to 51·4; p=0·0006) of patients aged 12 or older with Bardet-Biedl syndrome reached at least a 10% reduction in bodyweight
Study details
- Studied
- Patients aged 6 or older with Bardet-Biedl or Alström syndrome and obesity
- Compared with
- Placebo
- Main outcome
- Proportion aged 12+ achieving at least 10% bodyweight reduction at 52 weeks
- Sample
- 38 patients (19 setmelanotide, 19 placebo)
- Authors' conclusion
- Setmelanotide significantly reduced bodyweight in Bardet-Biedl syndrome; results were inconclusive in Alström syndrome.
- Limitations
- Small sample; inconclusive in Alström syndrome.
-
Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials.Humanssize not reportedPlacebo-controlledOpen-labelAbout 1 yearSingle-arm open-label multicentre phase 3 trials with placebo-controlled withdrawal
In 21 people with POMC or LEPR deficiency, 80% and 45% respectively lost at least 10% of body weight at about 1 year, with large falls in hunger; injection-site reactions and hyperpigmentation were near-universal.
Key resultEight (80%) POMC and five (45%) LEPR participants achieved at least 10% weight loss; most hunger score change -27·1% (p=0·0005) POMC and -43·7% (p<0·0001) LEPR
Study details
- Studied
- Individuals aged 6 or older with severe obesity from POMC or LEPR deficiency
- Compared with
- None (single-arm; 4-week placebo withdrawal)
- Main outcome
- Proportion with at least 10% weight loss at about 1 year
- Sample
- 21 participants: 10 in POMC trial and 11 in LEPR trial
- Authors' conclusion
- Results support setmelanotide for obesity and hyperphagia caused by POMC or LEPR deficiency.
- Limitations
- Single-arm open-label design, very small trials.
-
Setmelanotide for the treatment of acquired hypothalamic obesity: a phase 2, open-label, multicentre trial.Humans18 peopleOpen-label16 weeksPhase 2 open-label multicentre trial
In 18 patients with hypothalamic obesity, 89% reduced BMI by at least 5% at 16 weeks (mean -15%); nausea 61%, vomiting 33%, hyperpigmentation 33%.
Key result16 (89%) of 18 patients met the primary endpoint (p<0·0001); mean BMI reduction 15% (SD 10)
Study details
- Studied
- Patients aged 6 to 40 with obesity after hypothalamic injury or tumour
- Compared with
- Historic control rate (<5% reaching the BMI target)
- Main outcome
- Proportion with at least 5% BMI reduction
- Sample
- 18 patients enrolled
- Authors' conclusion
- Findings support setmelanotide as an effective treatment of hypothalamic obesity.
- Limitations
- Open-label, single-arm, small.
-
Setmelanotide in patients aged 2-5 years with rare MC4R pathway-associated obesity (VENTURE): a 1 year, open-label, multicenter, phase 3 trial.Humans12 peopleOpen-label52 weeksPhase 3 open-label multicentre trial (VENTURE)
In 12 children aged 2-5 with POMC/LEPR deficiency or Bardet-Biedl syndrome, BMI fell by 18% on average at 52 weeks with no serious adverse events.
Key resultTen (83%) of 12 reached a 0·2-point or greater BMI Z score reduction (95% CI 58·7-99·8); mean BMI change -18% (SD 13)
Study details
- Studied
- Children aged 2-5 with obesity and hyperphagia from POMC/LEPR deficiency or Bardet-Biedl syndrome
- Compared with
- None
- Main outcome
- BMI Z score reduction and percent BMI change
- Sample
- 12 children aged 2-5 enrolled
- Authors' conclusion
- First trial under age 6; results support setmelanotide as early intervention for obesity in this population.
- Limitations
- Open-label, 12 patients, no control group.
-
Evaluation of a melanocortin-4 receptor (MC4R) agonist (Setmelanotide) in MC4R deficiency.Humans + animals28 days (human trial)Combined in vitro, rodent and phase 1b human study
In cells, rodents and a 28-day phase 1b trial, setmelanotide caused weight loss in MC4R variant carriers, but less than in POMC-deficient patients; MC4R knockout mice did not respond.
Study details
- Studied
- MC4R mutant cells, rodents, and obese MC4R variant carriers
- Compared with
- Obese controls and POMC-deficient patients
- Main outcome
- MC4R signaling and weight loss
- Sample
- Cell, rodent and a 28-day Phase 1b human study; 369 MC4R variants annotated
- Authors' conclusion
- Setmelanotide led to weight loss in obese people with MC4R deficiency, but further studies are needed to see whether the weight loss is clinically meaningful in a subset.
- Limitations
- Short 28-day phase 1b human study; human sample size not given in abstract.
-
Setmelanotide in Bardet-Biedl Syndrome: A 52-Week Comparison of Phase 3 Trial Participants With a Matched Registry Cohort.Humanssize not reported52 weeksIndirect comparison of phase 3 trial participants with matched external registry cohort
Bardet-Biedl syndrome: 29 phase 3 patients on setmelanotide for 52 weeks were far more likely to be weight responders than 58 matched registry controls (58.6% vs 6.9%); external, not randomized, control.
Key result58.6% vs 6.9% met the primary endpoint.
Study details
- Studied
- Patients with Bardet-Biedl syndrome aged 6 years or older
- Compared with
- Matched CRIBBS registry cohort
- Main outcome
- Responder rate (>=0.3 BMI z-score fall or >=10% weight loss)
- Sample
- 29 treated phase 3 patients and 58 propensity-matched registry controls
- Authors' conclusion
- This indirect comparison provides additional strong evidence that setmelanotide improves weight outcomes in BBS over 52 weeks.
- Limitations
- Non-randomized external control.
-
Real-World Efficacy and Safety of Setmelanotide in Adults With Monogenic or Syndromic Obesity: A Prospective Cohort Study.Humans17 peopleNo control groupAverage follow-up 14.4 monthsProspective single-center cohort, routine care or early access
Real-world cohort of 17 adults and children with BBS, LEPR or POMC obesity: about 20% weight loss from pre-treatment maximum in year one and hunger down 62%, safety consistent with trials.
Key result20% weight reduction within the first year; hunger -62%, food craving -41%.
Study details
- Studied
- Patients with obesity due to Bardet-Biedl syndrome or biallelic LEPR or POMC variants
- Main outcome
- Weight, eating behaviour, safety
- Sample
- 17 patients (11 BBS, 4 LEPR, 2 POMC)
- Authors' conclusion
- Findings confirm long-term clinical benefit and a safety profile consistent with phase 3 data, with no new safety signals.
- Limitations
- Small uncontrolled single-center cohort.
-
Impact of the Melanocortin-4 Receptor Agonist Setmelanotide on MASLD and Kidney Function in Bardet-Biedl Syndrome.Humans26 patients with BBS (mean age 19.2 years)No control group6 monthsProspective monocentric observational cohort
26 patients with BBS followed 6 months on setmelanotide: BMI z-score fell 0.5, hyperphagia scores improved and 85% had resolved or stabilized liver steatosis; eGFR rose about 10 mL/min; uncontrolled.
Key resulteGFR increased up to 10.1 mL/min/1.73 m2 (95% CI 4.3-15.9); BMI z-score -0.5 (95% CI -0.6 to -0.3).
Study details
- Studied
- Patients over 6 years with genetically confirmed BBS and obesity
- Main outcome
- Liver steatosis (MASLD), kidney function, BMI z-score, hyperphagia
- Authors' conclusion
- Setmelanotide was associated with improvement in MASLD independent of BMI reduction and with increased glomerular filtration rate in BBS.
- Limitations
- No control group; short follow-up.
-
Safety and effectiveness of setmelanotide in young patients with severe obesity due to craniopharyngioma: a real world monocentric experience.Humans3 young adultsNo control group6-9 monthsRetrospective single-center case series
Three young adults with post-craniopharyngioma hypothalamic obesity: variable response, with two losing weight over 6-9 months and one stopping after continued weight gain; adverse effects mild.
Study details
- Studied
- Young adults with hypothalamic obesity after craniopharyngioma surgery
- Main outcome
- Weight, BMI, waist circumference, metabolic measures
- Authors' conclusion
- Setmelanotide may benefit selected patients with treatment-refractory hypothalamic obesity; small sample size supports further investigation.
- Limitations
- Three patients, retrospective, no control.
Reported side effects
- commonSkin hyperpigmentation [ref] [ref] [ref] [ref] [ref]
- commonInjection-site reactions [ref] [ref] [ref]
- commonNausea and vomiting [ref] [ref] [ref]
- commonDiarrhea [ref]
- reportedHeadache [ref]
- commonSerious adverse events (higher than placebo in the phase 3 hypothalamic obesity trial) [ref]
Studied only in small rare-disease populations; no evidence for use in common obesity.
26 registered human trials (5 active)
✓ positive · ✗ negative · ~ mixed · ? inconclusive, judged on each paper's own main outcome. Grades: A strong human evidence → D little or none. Papers and verdicts are drawn from PubMed, Europe PMC and Russian journals (CyberLeninka); not medical advice.
Registered clinical trials 26 on ClinicalTrials.gov · 5 active · 19 completed · 14 with posted results
| Trial | Status | Phase | People | Sponsor |
|---|---|---|---|---|
| Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity NCT07674290 · started 2023-01-01 |
Recruiting | Phase 4 | 200 | Tom Hühne |
| A Trial of Setmelanotide in Acquired Hypothalamic Obesity NCT05774756 · started 2023-04-26 · results posted |
Active, not recruiting | Phase 3 | 143 | Rhythm Pharmaceuticals, Inc. |
| A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) NCT06760546 · started 2025-09-23 |
Recruiting | Phase 3 | 39 | Rhythm Pharmaceuticals, Inc. |
| A Study of Setmelanotide in Patients With Prader-Willi Syndrome NCT06772597 · started 2025-03-04 |
Active, not recruiting | Phase 2 | 18 | Rhythm Pharmaceuticals, Inc. |
| Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a) NCT07496463 · started 2026-07-21 |
Enrolling by invitation | Phase 2 | 1 | Massachusetts General Hospital |
| Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity NCT03013543 · started 2017-02-10 · results posted |
Completed | Phase 2 | 213 | Rhythm Pharmaceuticals, Inc. |
| Long Term Extension Trial of Setmelanotide NCT03651765 · started 2018-07-15 · results posted |
Completed | Phase 2, Phase 3 | 205 | Rhythm Pharmaceuticals, Inc. |
| DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway NCT04963231 · started 2021-11-30 · results posted |
Completed | Phase 2 | 164 | Rhythm Pharmaceuticals, Inc. |
| Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients NCT02041195 · started 2014-01 · results posted |
Completed | Phase 1, Phase 2 | 99 | Rhythm Pharmaceuticals, Inc. |
| Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants NCT05046132 · started 2021-08-05 · results posted |
Completed | Phase 4 | 77 | Rhythm Pharmaceuticals, Inc. |
| Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants NCT01749137 · started 2013-01-14 · results posted |
Completed | Phase 2 | 74 | Rhythm Pharmaceuticals, Inc. |
| Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity NCT03746522 · started 2018-11-23 · results posted |
Completed | Phase 3 | 52 | Rhythm Pharmaceuticals, Inc. |
All 26 Setmelanotide trials, with countries and summaries · Search ClinicalTrials.gov · Recruiting trials for every peptide
Discussions elsewhere
Experiences and questions about Setmelanotide on other sites. Treat anecdotes with care.
Setmelanotide: questions people ask
What is Setmelanotide?
MC4 receptor agonist. Targets the brain's melanocortin-4 appetite pathway, which is broken in some rare genetic forms of obesity.
How much does Setmelanotide cost?
The cheapest Setmelanotide from an independently tested vendor is $6.00 per mg (Polaris Peptides, Setmelanotide 10mg, $60.00). Across 1 listings from 1 vendors the median is $6.00 per mg.
Where can I buy Setmelanotide?
1 vendors tested by Finnrick sell Setmelanotide. The cheapest per mg right now: Polaris Peptides ($6.00). 0 of them publish a lab report (COA) for Setmelanotide; compare lab scores and reports in the table above before buying.
Is Setmelanotide FDA approved?
FDA-approved as Imcivree for specific genetic obesity disorders.
Can Setmelanotide be compounded in the US?
FDA-approved (Imcivree) for specific genetic obesity syndromes. Compounding status for every peptide.
Does Setmelanotide work? What does the research say?
Evidence grade B (some human evidence), from 10 papers: Approved for rare genetic obesity on small trials: one 120-person phase 3 RCT, one 38-person RCT and open-label studies, all positive; under several hundred randomized. Setmelanotide (an MC4R agonist) has human evidence only in rare genetic or hypothalamic forms of obesity: one 120-person phase 3 RCT in acquired hypothalamic obesity, one small RCT in Bardet-Biedl/Alström syndrome, and several small open-label trials, all showing meaningful BMI and hunger reductions; it has not been shown to work in common obesity, and skin darkening, nausea and injection-site reactions are frequent. Added real-world and registry-comparison data in Bardet-Biedl syndrome and related conditions (small, uncontrolled or externally controlled) are consistent with the trials. See the papers.
Are there clinical trials of Setmelanotide?
ClinicalTrials.gov lists 26 registered trials of Setmelanotide: 5 active, 19 completed, 10 in phase 3, 14 with posted results. Examples: Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity (Recruiting, Phase 4, 200 people); A Trial of Setmelanotide in Acquired Hypothalamic Obesity (Active, not recruiting, Phase 3, 143 people); A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) (Recruiting, Phase 3, 39 people).
What dose of Setmelanotide was used in studies?
Setmelanotide is an approved drug. Imcivree: Starting dosage 0.5 mg once daily for 2 weeks (acquired hypothalamic obesity, age 4+), 2 mg once daily for 2 weeks (BBS or POMC/PCSK1/LEPR deficiency, age 12+), 1 mg (age 6 to <12) or 0.5 mg (age 2 to <6), then titrated per label tables; maintenance 3 mg once daily for patients aged 6 and older, weight-based for younger children; people aged 4-66 with acquired hypothalamic obesity (phase 3, randomised 2:1 vs placebo): 1.5 to 3.0 mg once daily; patients aged 6+ with Bardet-Biedl or Alström syndrome and obesity (phase 3): up to 3.0 mg once daily. These are amounts used in published studies or official labels, not a recommendation.
What are the side effects of Setmelanotide?
Reported in the research: Skin hyperpigmentation; Injection-site reactions; Nausea and vomiting; Diarrhea; Headache. Studied only in small rare-disease populations; no evidence for use in common obesity.