Amycretin

What it is

Amycretin is now called zenagamtide. The original papers call it NNC0487-0111: one acylated 68-amino-acid peptide designed to activate both GLP-1 and amylin receptors. Those names describe the same development candidate, not separate ingredients.

The oral and subcutaneous development programs use route- and formulation-specific study products. The name or a dual-receptor description does not authenticate a formulation, sequence, linker, acylation, concentration, purity, sterility, stability, or delivery system.

Why people care

Interest centers on large early weight-change estimates, the availability of both oral and subcutaneous development programs, and the transition into phase 3. Those features make route, trial phase, product identity, and approval boundaries especially important.

What humans actually show

Amycretin, now also called zenagamtide, is an investigational single-molecule GLP-1 and amylin receptor agonist with distinct oral and subcutaneous programs. Randomized early-phase studies report route-specific weight and safety findings, and phase 3 trials are active or planned, but the record does not establish FDA approval, long-term clinical benefit, comparative superiority, combination safety, or another product's identity.

• randomized human — 144 adults with overweight or obesity in a single-center phase 1 oral program; Route: Oral study formulation; Outcome: Treatment-emergent adverse events, pharmacokinetics, fasting glucose, and exploratory body-weight change through up to 12 weeks: In the highest studied 12-week oral group, mean body-weight change was reported as -13.1% versus -1.2% with placebo. Across the program, 89 participants reported 364 treatment-emergent adverse events; all were reported as mild or moderate, and gastrointestinal events predominated. The seam: Phase 1 and single-center; Body weight was exploratory rather than the primary safety endpoint; The longer multiple-dose evidence lasted 12 weeks; Does not establish maintenance, clinical outcomes, comparative benefit, rare risks, or another product's identity.
• randomized human — 125 adults with overweight or obesity in a five-part phase 1b/2a study; Route: Subcutaneous study formulation; Outcome: Treatment-emergent adverse events, pharmacokinetics, and body-weight change through up to 36 weeks: Estimated mean weight changes in the two 36-week groups were -24.3% versus -1.1% with placebo and -22.0% versus +1.9% with placebo. Gastrointestinal events were the most common treatment-emergent adverse events and were mainly mild or moderate. The seam: Early phase, single-center, and small placebo groups; Multiple parts had different durations and exposure patterns; A high number of withdrawals occurred, many reported for reasons unrelated to treatment-emergent adverse events; Does not establish long-term outcomes, active-comparator benefit, oral-formulation equivalence, or another product's identity.
• randomized human — Sponsor-reported subcutaneous analysis of 262 adults with type 2 diabetes within a 448-participant oral-plus-subcutaneous phase 2 program; Route: Subcutaneous study formulation; Outcome: HbA1c and body-weight change at 36 weeks: The sponsor reported a largest estimated mean HbA1c change of -1.71 percentage points versus -0.14 with placebo and a largest mean body-weight change of -14.6% versus -2.1% with placebo. The seam: Sponsor announcement and conference presentation rather than a peer-reviewed full outcomes paper; Covers the subcutaneous analysis rather than the full enrolled oral-plus-subcutaneous program; Background treatment and the trial population limit transferability; ClinicalTrials.gov had no posted results in the reviewed record; Does not establish FDA approval, comparative clinical benefit, or long-term safety.

Mechanistic and nonhuman evidence

• mechanistic — Human, mouse, and rat receptor systems in cell assays; Route: In-vitro receptor assays; Outcome: Activity at GLP-1 and amylin receptor systems: The original paper reported activity at GLP-1 and amylin receptor systems and described the candidate's linked single-peptide design. The seam: Mechanistic receptor evidence; Does not establish net clinical benefit, comparative superiority, or safety.
• animal — Mouse and rat metabolic and diet-induced-obesity models; Route: Experimental administration in nonhuman models; Outcome: Food intake, body weight, energy expenditure, insulin sensitivity, and liver-related measures: The original paper reported reduced food intake and body weight in diet-induced-obesity models and additional metabolic findings. The seam: Animal evidence; Cannot establish human efficacy, clinical outcomes, or long-term human safety; Does not authenticate another product.

FDA and U.S. status

Exact-active-ingredient Drugs@FDA API searches for AMYCRETIN and ZENAGAMTIDE returned no matching application, and neither name appeared on FDA's 2026 novel-drug approvals page in this dated review. ClinicalTrials.gov records active subcutaneous phase 3 studies and a not-yet-recruiting oral phase 3 study. Trial activity is not FDA approval, and the database results are not converted into a broader legal conclusion.

Risks and warning limits

• human trial: Gastrointestinal treatment-emergent adverse events predominated in the oral phase 1 program; all reported events in that program were classified as mild or moderate, and no deaths were reported.
• human trial: Gastrointestinal events were the most common treatment-emergent adverse events in the subcutaneous phase 1b/2a study and were primarily mild or moderate.
• not characterized: No FDA-approved zenagamtide or amycretin prescribing information was located in the dated exact-name searches, so candidate-specific labeled contraindications, warnings, pregnancy language, interactions, and postmarketing experience are not available to reproduce.

What remains unknown

• Whether the active and planned phase 3 programs will complete and confirm efficacy, safety, maintenance, and clinical outcomes remains unknown.
• Peer-reviewed full reporting of the completed 448-participant type 2 diabetes program, including the oral portion, was not identified in this pass.
• Long-term route-specific safety, uncommon adverse effects, outcomes after treatment ends, and comparative benefit and harm versus approved treatments remain unresolved.

Product identity and quality limits

• Amycretin, zenagamtide, and NNC0487-0111 identify a defined development candidate but do not authenticate a finished product.
• Oral and subcutaneous findings are route- and formulation-specific and cannot be treated as interchangeable without explicit evidence.
• A dual GLP-1/amylin description does not establish sequence, linker, acylation, concentration, purity, sterility, stability, or delivery-system equivalence.

What has been studied together

• Combined oral contraceptive and acetaminophen — coadministration studied: NCT06461039 registered coadministration with oral NNC0487-0111 to study pharmacokinetics and gastric emptying. The completed 43-participant phase 1 record had no posted results in the July 30 review, so registration does not establish absence of interaction or clinical clearance.
• Semaglutide or other metabolic-pathway products — no direct evidence: AMAZE comparator records study zenagamtide versus semaglutide, not coadministration. No controlled outcome evidence was identified for adding a separate GLP-1, amylin, GIP, or glucagon-pathway product to zenagamtide.

What people are hearing

These are claims this profile checks, not established conclusions.

• Claim under review: “Amycretin is already an approved weight-loss medicine because phase 3 trials are underway.”
• Claim under review: “The oral and subcutaneous amycretin programs support interchangeable conclusions.”
• Claim under review: “A single-molecule GLP-1/amylin agonist proves that adding other metabolic products is safe.”

Questions readers raise

• No reproducible community sample was collected for this profile.

The community-signal layer is not efficacy or safety evidence. Its current limits are:

• No reproducible community sample was collected for this research draft.
• Online product identity cannot be verified from a name or self-report.
• Concurrent medicines, behaviors, and clinical conditions would confound anecdotal outcomes.
• Anecdotes cannot establish efficacy, safety, approval, interaction safety, or product quality.

What would change this answer

• Completed, fully reported phase 3 studies with route-specific efficacy, safety, maintenance, and clinical outcomes would materially change the evidence assessment.
• FDA approval documentation and current prescribing information for a defined zenagamtide product would change the regulatory and labeled-warning sections.
• Posted results or a peer-reviewed report from the completed interaction study would change the narrow coadministration boundary.

Sources and records

• WADA — 2026 Prohibited List

• Drugs@FDA exact-active-ingredient API search for amycretin — U.S. Food and Drug Administration
• Drugs@FDA exact-active-ingredient API search for zenagamtide — U.S. Food and Drug Administration
• FDA novel-drug approvals for 2026 — U.S. Food and Drug Administration
• FDA current compounding-risk page — U.S. Food and Drug Administration
• Safety, tolerability, pharmacokinetics, and pharmacodynamics of oral amycretin: first-in-human phase 1 trial — The Lancet / PubMed
• Subcutaneous amycretin phase 1b/2a randomized controlled study — The Lancet / PubMed
• The effect of amycretin, a unimolecular glucagon-like peptide-1 and amylin receptor agonist, on body weight and metabolic dysfunction in mice and rats — EBioMedicine / PubMed
• NCT05369390: oral NNC0487-0111 first-in-human study — ClinicalTrials.gov
• NCT06064006: subcutaneous NNC0487-0111 study — ClinicalTrials.gov
• NCT06542874: oral and subcutaneous NNC0487-0111 phase 2 study in type 2 diabetes — ClinicalTrials.gov
• Novo Nordisk June 2026 phase 2 zenagamtide type 2 diabetes announcement — Novo Nordisk
• NCT06461039: NNC0487-0111 oral-contraceptive and gastric-emptying interaction study — ClinicalTrials.gov
• NCT07339423: AMAZE 1 phase 3 subcutaneous NNC0487-0111 study — ClinicalTrials.gov
• NCT07720271: AMAZE 9 phase 3 oral zenagamtide study — ClinicalTrials.gov
• NCT07668414: AMAZE 7 zenagamtide versus semaglutide comparator study — ClinicalTrials.gov
• NCT07400107: AMAZE 8 NNC0487-0111 versus semaglutide comparator study — ClinicalTrials.gov
• ClinicalTrials.gov intervention search for amycretin, zenagamtide, or NNC0487-0111 — U.S. National Library of Medicine
• PubMed Title/Abstract search for amycretin or zenagamtide — U.S. National Library of Medicine