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Unimolecular GLP-1/amylin receptor agonist peptide · Fact sheet

Zenagamtide (amycretin)

Also known as Zenagamtide · Amycretin · NNC0487-0111

Zenagamtide, previously called amycretin, is a single molecule targeting GLP-1 and amylin receptors. Early oral and injectable trials found weight-loss signals; phase 3 registration does not establish completed outcomes or FDA approval.

In clinical trialsEarly human evidence
Weight & metabolismSpecific conditions

What is Zenagamtide (amycretin)?

It combines receptor activities in one molecule, unlike CagriSema, which combines two separate drugs.

Oral and subcutaneous formulations have different exposure and study schedules.

Benefits & claims

Interest centers on appetite and weight management through complementary receptor effects.

What the evidence supports

  • Both early programs supported further investigation rather than an approved regimen.
  • The injectable trial reported frequent gastrointestinal events and many withdrawals.
  • A planned cardiovascular-outcomes trial cannot establish cardiovascular protection before results are available.
Research areas
  • Investigational weight management
  • Type 2 diabetes development
  • Registered cardiovascular-outcomes research

Dosage & frequency

Human study context

A short oral phase 1 component supplies an exposure reference; it is not interchangeable with weekly injectable development.

Oral amycretin first-in-human study, part B (NCT05369390)

Adults aged 18–55 with overweight; part B BMI 25.0–34.9

Amount
3, 6 or 12 mg in separate multiple-dose groups
Frequency
Once daily during a ten-day intervention, followed by 21 days of follow-up
Route studied or labeled
Oral study formulation

Part B was a pharmacology and safety component. Separate longer oral titration groups and weekly injectable cohorts used different schedules; no approved routine regimen follows.

Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, double-blind, randomised, placebo-controlled trial.
How to read these amounts

An approved regimen belongs to a specific product, indication, and population. A study regimen describes what researchers tested; it does not establish a prescription or a safe self-use protocol. Products, routes, and formulations are not interchangeable. A prescriber uses the full label and individual clinical circumstances.

Personal accounts may describe amounts, schedules and outcomes beyond clinical research. They do not establish a regimen. Read the reported experiences

Formulations, interactions & practical context

Formulation differences

  • Oral and subcutaneous formulations have different exposure and study schedules.

Interactions & precautions

  • The reviewed sources do not establish a comprehensive human interaction profile for this exact substance or combination.

What is still unresolved

  • Long-term cardiovascular and safety outcomes
  • Durability and effects after stopping treatment
  • Differences between oral and injectable products
Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, double-blind, randomised, placebo-controlled trial. Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study. AMBIENCE phase 3 registry NCT07861100

Side effects & risks

  • Gastrointestinal adverse effects were frequent in early studies and tended to increase with exposure.
  • Short dose-escalation work cannot establish rare, chronic or formulation-independent safety.

This is a summary of the cited evidence, not a complete product label. A lack of human safety data does not establish safety.

Clinical research

Early human evidence

Published first-in-human oral and phase 1b/2a subcutaneous studies focused on safety and pharmacology, with exploratory weight outcomes. The subcutaneous study had substantial attrition.

Studies

Personal experiences

Reports describe what someone noticed. They cannot establish cause, typical results, or how often a side effect happens. Amounts and schedules describe the individual account, not an effective or safe dose. Product identity and strength may be unverified, and missing details are left explicit.

No attributable personal accounts were found in the sources reviewed.

Approval status

Zenagamtide remains investigational and has no FDA-approved product. The AMBIENCE cardiovascular study is registered as phase 3 and was not yet recruiting in the reviewed registry record; registration is not a trial result.

Phase 3 research; no FDA-approved product

Approval covers the labeled product, use and population. A trial phase does not establish success; a stopped program is not ongoing research.

Open questions

  • Long-term cardiovascular and safety outcomes
  • Durability and effects after stopping treatment
  • Differences between oral and injectable products

Summary

A planned cardiovascular-outcomes trial cannot establish cardiovascular protection before results are available.

Sources

Medical evidence and regulatory sources are listed here. Personal reports are linked separately in the experiences section.

  3. clinical trialsAMBIENCE phase 3 registry NCT07861100

    Sponsor-submitted phase 3 cardiovascular-outcomes registration; not yet recruiting in the reviewed record, with no outcome results.

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