Setmelanotide dosage and evidence
Written by Aaron CuhaReviewed Sep 2026
The short answer
Setmelanotide is an FDA-approved shot for rare genetic types of obesity, where a broken gene stops the brain from feeling full.
Evidence grade for Setmelanotide: Limited. The rule: people have taken it in a published study, but fewer than 100 of them. The sum on this page: 1 completed trial, 38 people given it. A grade counts how much has been done to people, not whether it works.
- People given it
- 38
- Human studies
- 1
- Found nothing
- 0
Dose
Approved medicine. No human dose established for unlabelled uses
Labeled amounts sit on the prescribing information. This page records what trials measured, not a personal dose.
FDA-approved (Imcivree) for certain rare genetic causes of obesity
4 effects reported, 2 unwanted, 2 wanted, by people using it, not a trial
Goal pages: Fat loss and metabolism, Skin, hair and appearance
In plain English
In plain English, from Aaron
This is how I would explain it to a friend. The evidence, with the numbers, is further down the page.
Setmelanotide is a shot for a few rare genetic kinds of obesity. In these people, a broken gene stops the brain from getting the signal that says you are full. This drug switches that signal back on. It is sold as Imcivree. It is not a general weight loss drug.
What people take it for
- Weight loss when a rare gene fault causes constant hunger.
- Less hunger in Bardet-Biedl syndrome and similar gene faults.
What studies in people showed
The biggest study had 38 people with two rare syndromes, Bardet-Biedl and Alstrom. They took the drug or a dummy shot, and nobody knew which. Among people 12 and older with Bardet-Biedl, 32.3 percent lost at least a tenth of their body weight in a year. There were too few Alstrom patients to say anything. Two smaller studies had no dummy group. After about a year, 8 of 10 people with a POMC gene fault lost at least a tenth of their weight. So did 5 of 11 people with a LEPR gene fault. Their hunger scores fell 27 and 44 percent. Nearly everyone got darker skin and a reaction where the needle went in.
What people report
Reports, not study results
The good
- In the studies on this page, most people with a POMC gene fault lost at least a tenth of their body weight.
- Hunger scores dropped in the gene fault studies.
The bad
- Darker skin. Nearly everyone in the gene fault studies got it.
- Red or sore skin where the needle went in. This was also near universal in those studies.
Where these come from: Everything here is from the human studies on this page. We have not collected forum or user reports for this drug yet.
My bottom line
For the few people with these gene faults, this is a real answer to hunger. For everyone else, it is the wrong drug. You need a gene test first, not a guess.
An opinion, not a finding. I am a coach, not a doctor.
What it has been measured to do
Measured in people
Goals Setmelanotide has been tested for in people, biggest studies first. We count only what the studies on this page say, so the real numbers may be higher.
- Losing weight38 people · 2 studies
- Feeling less hungryno headcount stated · 1 study
- Skin, wrinkles and elasticityno headcount stated · 1 study
33 of the 36 indexed goals have no study of any kind behind Setmelanotide
No study in people, animals or cells on this page reports a result for these. That does not prove Setmelanotide does nothing for them. It does mean anything you have heard about Setmelanotide and one of these did not come from a study cited here.
Show full evidence
What is Setmelanotide?
Setmelanotide is an FDA-approved shot for rare genetic types of obesity, where a broken gene stops the brain from feeling full.
Setmelanotide switches on MC4R, a brain switch that tells you that you are full. It was approved as Imcivree in November 2020. It is for obesity caused by faults in the POMC, PCSK1 or LEPR genes, and later for Bardet-Biedl syndrome. In those people, a broken gene higher up the chain stops the fullness signal. This drug switches it back on. The biggest study had 38 patients with Bardet-Biedl or Alstrom syndrome, both rare. Among those aged 12 or older with Bardet-Biedl, 32.3% lost at least 10% of their body weight in 52 weeks. In other studies, 8 of 10 people with POMC faults and 5 of 11 with LEPR faults lost at least 10% of their body weight in about a year. Hunger scores fell 27% and 44%. Nearly everyone got darker skin and reactions where they injected. It is not a general weight-loss drug.
How does Setmelanotide work?
It switches on MC4R, the brain's fullness switch. That brings back the fullness signal that the broken genes shut off.
The evidence, in charts
Fig. 1a · how many people
38people, across 1 study in people cited here
| Study | People | Share |
|---|---|---|
| The Lancet Diabetes & Endocrinology 2022 | 38 | 100% |
The whole total is one study of 38. Counts are the number of people each study on this page says it signed up. That includes studies that only watched people and gave nobody the compound. 1 more study in people gives no headcount and is not counted here. Studies still signing people up are left out, and only studies cited on this page are counted.
Fig. 1b · evidence mix
2 of 3 sources here are studies in people. The rest is not.
- Study in people · done in people267%
- Review of studies · sums up other studies133%
Counted from the list of sources on this page. It counts only what we cite, so there may be more studies out there. A review counts once, however many studies it sums up.
Fig. 2 · evidence over time
Sources here come from just two years, 2020 and 2022.
Too few different years on this page to draw a timeline.
Fig. 3 · legal status at a glance
US
Approved
UK
Approved
AU
Approved
CA
Approved
Approved in all four countries shown. This is what the law says, not a verdict on the science. See Legal status below for the full text and any notes.
Fig. 5 · what the molecule is
- Kind of compound
- Peptide
- Molecule weight
- 1,117.3 Da
- Half-life
- About 11 hoursMedium, 6 to 24 hours
- Chain length
- None on file
No amino acid sequence is on file for Setmelanotide, so none is drawn rather than guessed from a name.
The studies we cite
- Study in people2020Efficacy 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
In rare genetic forms of obesity most patients lost serious weight, and there was nobody to compare them against. After about a year, 8 of 10 people with one gene fault and 5 of 11 with the other had lost at least a tenth of their body weight. Reported hunger fell by roughly a third in one group and nearly half in the other. Nearly everyone got darker skin and reactions where they injected. These gene faults are very rare, and this says nothing about ordinary obesity.
At about one year, 8 of 10 (80%) POMC-deficiency and 5 of 11 (45%) LEPR-deficiency participants lost at least 10% of body weight, with hunger scores down 27% and 44%; hyperpigmentation and injection-site reactions were near-universal.
- Study in people2022Efficacy and safety of setmelanotide in patients with Bardet-Biedl syndrome and Alstrom syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period
It helped a minority of patients with one rare syndrome, and left the other syndrome unanswered. 38 patients with Bardet-Biedl syndrome or Alstrom syndrome took setmelanotide or a dummy injection for a year, and nobody involved knew which. Among those aged 12 and over with Bardet-Biedl, 32.3% lost at least a tenth of their body weight. Too few Alstrom patients took part for any conclusion. Thirty-eight people is a very small trial, which is normal for diseases this rare.
38 patients: 32.3% of those aged 12 or older with Bardet-Biedl syndrome reached at least 10% weight loss after 52 weeks (p=0.0006); results in Alstrom syndrome were inconclusive.
- Review of studies2020FDA approves first treatment for weight management for people with certain rare genetic conditions
The FDA's announcement on November 27, 2020. It approved Imcivree for long-term weight control in people 6 and older with obesity caused by POMC, PCSK1 or LEPR gene faults.
November 27, 2020 FDA announcement approving Imcivree for chronic weight management in patients 6 and older with obesity due to POMC, PCSK1 or LEPR deficiency.
Where to buy Setmelanotide
Setmelanotide is an approved medicine. The approved product comes from a pharmacy, with a prescription. The vials below are sold “for research” and are not the approved drug.
3 sellers list Setmelanotide in our latest read. They are ranked by trust score, then by archive rating, then by certificate tier, then by the lowest price per milligram. Archive evidence is counted before source-backed. Each path is out of 4, and the two are not added. A higher price does not raise the score. The letter is the certificate chip. 0 of them have a published certificate that names Setmelanotide.
Some seller links may pay this site when you buy through them. A payment never changes a seller's tier or rank, and no seller has a say in any page.
| Seller | Trust score | Vial sizes | From, per mg | Certificate for Setmelanotide | Seller link |
|---|---|---|---|---|---|
| Canlab International | 37 WeakSource-backed 1 of 4. Archive evidence 1 of 4.C | 15 mg | $4.40 | None found for Setmelanotide | View |
| Boston Molecules | 28 InsufficientSource-backed 1 of 4. Archive evidence 1 of 4.C | 10 mg | $81.0 | None found for Setmelanotide | View |
| Polaris Peptides | 15 InsufficientSource-backed 1 of 4. Archive evidence 0 of 4.Letter withheld | 10 mg | $6.00 | None found for Setmelanotide | View |
- LC Lab-confirmed: the issuing laboratory echoed this certificate back
- A Current certificate, independent laboratory named, laboratory not yet checked
- B Certificate published, but no laboratory link, older than a year, or the laboratory did not recognise the published lookup
- C No certificate could be read
Every listing and vial size for Setmelanotide · How the trust score is counted
Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.
Common questions
Has Setmelanotide been tested in people?
Yes. 38 people given it across 1 completed trial cited here, 0 of which found nothing. Setmelanotide is an FDA-approved shot for rare genetic types of obesity, where a broken gene stops the brain from feeling full.
What is the Setmelanotide dosage?
Approved medicine. No human dose established for unlabelled uses. Labeled amounts sit on the prescribing information. This page records what trials measured, not a personal dose. FDA-approved (Imcivree) for certain rare genetic causes of obesity
Is Setmelanotide FDA-approved?
FDA-approved (Imcivree) for certain rare genetic causes of obesity
Is setmelanotide a general weight-loss drug?
No. It is approved only for rare genetic types of obesity that affect the brain's fullness pathway. It is not for common obesity.