Is amycretin FDA-approved, and what does the research show?

What is amycretin?

Amycretin is an investigational peptide drug from Novo Nordisk ², ³. By June 2026 the company was calling it zenagamtide ³; the papers write "zenagamtide (formerly amycretin)" and the company "zenagamtide, also known as amycretin" ¹, ³, ¹⁰. Its trial records carry the code name NNC0487-0111 ⁸.

It is one molecule built to act on the GLP-1 and amylin receptors; in cell tests it also activates the calcitonin receptor ², ⁶. GLP-1, glucagon-like peptide-1, is a gut hormone that prompts the pancreas to release insulin after a meal ⁴. Amylin is a second hormone made in the body, and the first trial's record describes both as hormones that "help the body to feel full" ⁵.

Is amycretin FDA-approved?

Amycretin is not FDA-approved: Drugs@FDA lists no approved amycretin, zenagamtide or NNC0487-0111 product as of November 9, 2026 ⁷. It is an investigational drug in phase 3 trials ⁸, ³. Novo Nordisk's release of June 6, 2026 calls it "investigational" and "under clinical trial development" ³. The company runs separate programs for adults with type 2 diabetes and for adults with overweight or obesity ³. Its pipeline page lists the weekly injection in phase 3 for both, and the daily tablet in phase 3 for obesity ⁹.

No approved product means no FDA label, so no FDA prescribing or safety information exists for amycretin ⁷. Its phase 2 record says "NNC0487-0111 is a new medicine which cannot be prescribed by doctors" ¹². Clinical trials are the only setting in which it is given in any source opened ⁸, ¹². No source opened gives a filing date or a company forecast of an approval decision ³, ⁹.

See the FDA status of every peptide, updated weekly.

How does amycretin work?

Amycretin is a unimolecular agonist: one molecule that switches on more than one receptor ¹, ². In cell-based systems it activated the human GLP-1, amylin and calcitonin receptors, and the 2026 papers describe it as an agonist of all three ⁶, ¹. Drugs that act on the GLP-1 receptor stimulate insulin release after food, slow stomach emptying and increase satiety through the brain's hypothalamus ⁴. Amylin's part is described in the first trial's record as helping "the body to feel full" ⁵.

Studied in rats: rats given amycretin for 21 days ate 47% less energy and weighed 18% less than rats given an inactive vehicle, while energy expenditure was maintained ⁶. No published trial compares amycretin with a GLP-1 drug alone in people; AMAZE 7, a phase 3 trial against semaglutide, began recruiting in September 2026 ¹³.

What does the research show?

Studied in people: a first-in-human phase 1 trial, 144 adults aged 18 to 55 with overweight or obesity, oral tablets, safety as the primary endpoint ¹¹. Phase 1 is the first stage of testing in people ¹¹. It was randomized, double-blind and placebo-controlled: participants were assigned by chance to amycretin or an inactive look-alike, and neither they nor the staff knew which ¹¹. Dosing ran from a single dose to 12 weeks, at one research unit in San Antonio, Texas ¹¹. Weight change was an exploratory measure, one recorded but not the trial's test, and the abstract gives no weight figure ¹¹.

Studied in people: a phase 1b/2a trial, randomized and placebo-controlled, 125 adults aged 18 to 55 with overweight or obesity, once-weekly injection, up to 36 weeks ². A phase 1b/2a trial is an early-stage trial that begins to test doses ². It ran at the same single center, and entry required a body mass index, a weight-for-height measure, of 27.0 to 39.9 ². The 101 on amycretin were split across five parts, a single-dose part and four parts that each built to a different dose; 24 received placebo ².

Estimated mean weight loss at week 36 was 24.3% against 1.1% on placebo in the highest-dose part, and 22.0% against a 1.9% gain on placebo in the next-highest ². The two lower-dose parts gave 16.2% against a 2.3% gain at week 28 and 9.7% against a 2.0% gain at week 20 ². The authors report that "a large number of participants withdrew from the study," many for reasons unrelated to adverse events ².

Studied in people: an oral phase 2 trial, the middle stage of testing, which compares doses, randomized, double-blind and placebo-controlled, 186 adults with type 2 diabetes, 36 weeks ¹. Participants were on metformin with or without an SGLT2 inhibitor, a second class of diabetes tablet, at 83 sites in 11 countries ¹. Entry required an HbA1c, the three-month blood sugar measure, of 7.0 to 10.0% and a body mass index of 23.0 to under 50.0 ¹. The Lancet printed a correction to the trial's paper in its issue of October 24, 2026 ¹⁴. It corrects one sentence of the paper's discussion, on how many weeks two dose groups spent at their final dose ¹⁴.

HbA1c fell by 0.9, 1.3 and 1.4 percentage points in the three dose groups of 54, 51 and 51 participants ¹. The differences from the 30 on placebo were 0.5, 0.99 and 1.09 points, with 95% confidence intervals of 0.04 to 1.04, 0.49 to 1.49 and 0.59 to 1.59 ¹. The primary analysis included all randomized participants, using their measurements while on treatment and before any rescue medication ¹. The abstract gives no weight figure for the oral trial ¹.

Studied in people: the same program's injection trial, 262 adults with type 2 diabetes, 225 on amycretin across six dose groups and 37 on placebo, 36 weeks ¹⁰. HbA1c fell by 0.9 to 1.7 percentage points across the six groups from a mean baseline of 7.8% ¹⁰. The differences from placebo ran from 0.77 points, with a 95% confidence interval of 0.28 to 1.26, to 1.56 points, with an interval of 1.07 to 2.05 ¹⁰.

Novo Nordisk reports a mean weight loss of up to 14.6% in the highest dose group against 2.1% on placebo, from a mean baseline of 99.2 kilograms ³. Those are the company's figures; the published abstract gives none ¹⁰. The company adds that the highest two groups had reached their final dose only four and eight weeks before the end ³.

No phase 3 result is published, and no trial opened ran past 36 weeks ¹, ², ¹¹, ¹⁰. AMAZE 1, a phase 3 trial of 1,150 adults with obesity and without diabetes, measures weight change at 84 weeks and is recruiting, with primary completion expected in June 2029 ⁸. AMAZE 9 tests the daily tablet in 950 adults with obesity over 76 weeks ¹⁵.

Two outcome trials have begun or are about to. AMBIENCE, 8,500 adults with established atherosclerotic cardiovascular disease and overweight or obesity, measures heart attacks, strokes, cardiovascular deaths and heart failure hospitalizations or urgent visits ¹⁶. Its primary completion is expected in 2030 ¹⁶. HF-POLARIS, 5,610 adults with obesity and heart failure with preserved or mildly reduced ejection fraction, measures cardiovascular death and heart failure hospitalization or urgent visits ¹⁷.

Novo Nordisk said in June 2026 that it planned to start phase 3 trials in type 2 diabetes in the second half of 2026 ³. A phase 3 trial in type 2 diabetes, AMBITION 7, began in August 2026 ¹⁸.

What are the side effects?

Gastrointestinal effects were the most common adverse events in every amycretin trial. In the first-in-human trial, 89 (62%) of 144 participants reported 364 adverse events, all mild or moderate, rising in frequency with dose ¹¹. Gastrointestinal events made up 180 (49%) of the 364 and affected 72 (81%) of the 89 who reported any ¹¹. No deaths were reported ¹¹.

The weekly-injection phase 1b/2a study, which enrolled 125 adults whose body mass index put them in the overweight or obesity range, also saw gastrointestinal events most often ². The majority were mild to moderate and had resolved by the end of the study ². The authors write that "a high frequency of gastrointestinal events was reported" and that "rates were similar to those seen in early-phase studies of these molecules" ².

In the oral phase 2 trial in type 2 diabetes, gastrointestinal events affected 26%, 41% and 47% of the three dose groups, against 23% of the 30 on placebo ¹. Serious adverse events occurred in 7 of the 156 on amycretin and in none of the 30 on placebo; no deaths occurred ¹. In the injection trial, 21 (8%) of the 261 who received a dose had a serious adverse event, three of them on placebo, and no deaths occurred ¹⁰. That trial escalated doses on a fixed schedule, and the company says a participant who could not tolerate the planned dose stopped treatment for good ³.

FDA has approved no amycretin product, so no FDA label exists to quote on safety or contraindications ⁷. The phase 3 trial AMAZE 1 excludes people with type 1 or type 2 diabetes and people with an HbA1c of 6.5% or more ⁸. It also excludes people treated before screening with a GLP-1 drug or an amylin analog ⁸. Those are trial entry rules, not medical guidance.

In sport

Amycretin, zenagamtide and NNC0487-0111 are not named on WADA's 2026 Prohibited List, and the list mentions neither GLP-1 nor amylin ¹⁹. WADA is the World Anti-Doping Agency.

Its section S0 reads: "Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved only for veterinary use) is prohibited at all times" ¹⁹. Of the regulators, only FDA's records were read for amycretin, and Novo Nordisk describes it as "under clinical trial development" ⁷, ³.

What JumpstartMD offers

JumpstartMD does not prescribe amycretin. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 9, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.