Digestive & weight Amylin + GLP-1 co-agonist
Amycretin
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Amycretin is an investigational single-molecule drug that activates both the GLP-1 receptor and the amylin receptor, being developed by Novo Nordisk in subcutaneous and oral forms for weight management. In a 2025 phase 1b/2a trial of 125 adults with overweight or obesity, the 60 mg group lost 24.3% of body weight at 36 weeks versus 1.1% on placebo (p < 0.0001), though many participants withdrew. As of 2026 it is not approved anywhere and is moving into Phase 3 testing.
At a glance
- FDA status
- Investigational peptide, not approved by the FDA or any regulator
- What it is
- GLP-1 and amylin receptor co-agonist, studied as both an injection and a tablet
- Research
- Human evidence from early-phase (Phase 1/2a) trials in overweight and obesity
- Results
- Dose-dependent weight loss, but only in short studies with high discontinuation
- Evidence strength
- Moderate research
Summary
Amycretin is an investigational drug that targets GLP-1 and amylin receptors for weight management. See how it works and what early trials have found so far.
What is amycretin?
Amycretin, also known as zenagamtide, is an experimental drug that combines two hormone actions in one molecule: it activates the GLP-1 receptor and the amylin receptor at the same time. It is being developed by Novo Nordisk for weight management, in a once-weekly subcutaneous form and a once-daily oral form. It is investigational and has not been approved for any use.
How does it work?
Amycretin combines two appetite-signaling actions in one molecule. The first is activation of the GLP-1 receptor, the same incretin target as drugs like semaglutide. Switching it on:
- Raises insulin release when blood sugar is high
- Slows how fast the stomach empties
- Reduces appetite
The second is activation of the amylin receptor, which responds to amylin, a pancreatic hormone that promotes a feeling of fullness.
Each pathway curbs eating on its own, and the reason for building both into a single drug is that the two fullness signals may add together to reduce food intake more than either does alone. This is the proposed mechanism; whether it produces lasting benefit is what clinical trials are meant to establish.
Is it FDA-approved?
Safety note
Status: Investigational peptide, not approved by the FDA or any regulator
Category: In clinical trials · Primary body area: Digestive & weight
No. Amycretin is investigational and not approved by the FDA or any other regulator. According to Novo Nordisk, both the subcutaneous and oral forms are advancing into Phase 3 development for weight management after early-phase results. The Phase 3 trial AMAZE 1 began recruiting in February 2026.
What does the research show?
Editor’s note
Evidence strength: Moderate research (2 human · 0 animal/cell studies)
It has shown dose-dependent weight loss, but only in small, short, early-phase trials with high dropout, and no Phase 3 efficacy data exist.
The human data so far come from early-phase trials. According to PubMed, the two published trials reported the following:
| Trial | Duration | Findings |
|---|---|---|
| Phase 1b/2a trial of the subcutaneous form in 125 adults with overweight or obesity | Up to 36 weeks | Dose-dependent weight reductions; weight fell 24.3% on 60 mg versus 1.1% on placebo at 36 weeks (p < 0.0001); mostly mild to moderate gastrointestinal side effects but a notably high rate of withdrawal and discontinuation |
| First-in-human trial of the oral form | 12 weeks | Focused mainly on safety and drug levels, with exploratory weight-change signals |
These are small, short studies; no Phase 3 efficacy data are available yet, so amycretin's longer-term effect and tolerability remain unproven.
Sources: the Phase 1b/2a subcutaneous amycretin trial (Dahl et al., The Lancet, 2025, DOI: 10.1016/S0140-6736(25)01185-7) and the first-in-human oral amycretin trial (Gasiorek et al., The Lancet, 2025, DOI: 10.1016/S0140-6736(25)01176-6), both indexed on PubMed; and Novo Nordisk development updates. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
2 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
- [3]
- [4]
AMAZE 1 began recruiting in February 2026
- ClinicalTrials.gov NCT07339423
- [5]
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