Amycretin — Safety, Research, Risks & Legal Status

Not medical advice. Amycretin is discussed here for informational and harm-reduction purposes only. We do not endorse use, and any dosing context is informational, not a protocol.

Also known as	NN 9487
Category	GLP-1 / Metabolic
Developer	Novo Nordisk (development code NN 9487)
Drug class	First-in-class unimolecular dual GLP-1 receptor / amylin receptor agonist
Formulations studied	Subcutaneous injection (weekly) and oral tablet (both in human trials)
Best Phase 1b/2a weight loss result (SC)	Approximately 22% mean weight loss at 20 mg weekly over 36 weeks (Phase 1b/2a)
Best oral Phase 1 weight loss result	Approximately 13% mean weight loss at highest oral regimen over 12 weeks
Current development stage	Phase 3 initiation anticipated 2026; NDA submission projected 2027-2028
US legal status	Not FDA-approved. Amycretin is an investigational new drug (IND) under active clinical development by Novo Nordisk. It is not legally available through any commercial, compounding, or direct-access channel in the United States. Phase 3 trials are anticipated to begin in 2026; an NDA submission is projected for 2027-2028 at the earliest. Any source offering amycretin outside of an enrolled clinical trial is operating outside regulatory bounds.

What is Amycretin?

Amycretin is a first-in-class unimolecular dual agonist targeting both the GLP-1 receptor and the amylin receptor. Developed by Novo Nordisk under the development code NN 9487, it is a single peptide molecule with two covalently linked pharmacophore domains acting simultaneously on two distinct metabolic pathways. It is being evaluated in both subcutaneous and oral formulations for obesity and type 2 diabetes. As of mid-2026, the compound has completed Phase 1b/2a and is entering Phase 3 trials.

How it works

Amycretin carries two distinct receptor-active domains in a single molecule. The GLP-1 domain activates GLP-1 receptors on pancreatic beta cells, gut enteroendocrine cells, and hypothalamic neurons, slowing gastric emptying, suppressing postprandial glucagon secretion, and reducing appetite via gut-brain signaling. The amylin domain mimics endogenous amylin, a peptide co-secreted with insulin from pancreatic beta cells; it acts on amylin receptors in the hindbrain (area postrema and nucleus of the solitary tract) to amplify satiety signaling, further reduce energy intake, and additionally slow gastric emptying. Because the two mechanisms engage overlapping but distinct neural and peripheral circuits, preclinical and early human data suggest synergistic weight reduction exceeding what either class alone produces at equivalent doses. The amylin receptor component distinguishes amycretin from existing dual GLP-1/GIP agonists such as tirzepatide.

Background & history

Amycretin emerged from Novo Nordisk's pipeline as the company's research into amylin biology intersected with its established GLP-1 expertise. The rationale for combining the two mechanisms draws on decades of research showing that amylin and GLP-1 have complementary central and peripheral satiety effects. A first-in-human oral Phase 1 trial (NCT05369390) reported 12-week data in 2024, demonstrating 13% mean weight loss at the highest oral regimen and establishing bioavailability of the tablet formulation. A separate subcutaneous Phase 1b/2a trial (NCT06064006) reported 36-week data presented at the American Diabetes Association (ADA) 2025 Scientific Sessions and published in The Lancet, showing up to 22% mean weight loss at 20 mg weekly. Novo Nordisk announced Phase 3 initiation for obesity and type 2 diabetes in early 2026 following those results. An NDA submission is projected for 2027-2028, with conditional forecasts of potential approval around 2030, all contingent on Phase 3 outcomes.

What the research says

Human data exist from two completed early-phase programs. In the subcutaneous Phase 1b/2a (36-week, randomized controlled trial, NCT06064006, published PMID 40550231), dose-dependent weight loss was observed: approximately 9.7% at 1.25 mg weekly, 16.2% at 5 mg weekly, and 22% at 20 mg weekly. A diabetic subgroup showed meaningful HbA1c reduction. In the oral Phase 1 first-in-human study (NCT05369390, published Lancet PIIS0140-6736(25)01176-6), the highest oral regimen produced approximately 13% weight loss over 12 weeks. These figures are from early-phase studies with relatively small sample sizes and short-to-medium duration; Phase 3 data are required before efficacy and safety can be considered established to regulatory standards. Preclinical mechanistic data are available in murine and rat models (PMC12309853; PMID 40706446). A Japanese obesity cohort study is registered (NCT06049329). Phase 3 trials for obesity and type 2 diabetes are anticipated to begin enrollment in 2026.

Reported effects

Dose-dependent body weight reduction observed in Phase 1b/2a human trials (up to approximately 22% mean loss at highest subcutaneous dose over 36 weeks)
Appetite suppression via dual GLP-1 and amylin receptor engagement in gut-brain circuits
Slowing of gastric emptying through both receptor pathways
Suppression of postprandial glucagon secretion via the GLP-1 arm
Hindbrain satiety amplification via amylin receptor activation in the area postrema and nucleus of the solitary tract
HbA1c reduction observed in diabetic subgroup in Phase 1b/2a trial
Oral formulation demonstrated approximately 13% weight loss in first-in-human 12-week data (Phase 1)

Dosing & administration (informational)

Published Phase 1b/2a trials evaluated subcutaneous doses ranging from 1.25 mg to 20 mg administered weekly; the oral Phase 1 trial tested multiple escalating regimens up to a highest reported dose producing 13% weight loss at 12 weeks. These ranges appear in the primary literature strictly as clinical trial protocol details and are not a dosing protocol or clinical recommendation. Amycretin is not approved for any indication. Dose selection, titration, and administration route for any potential future approved use will be determined by regulatory review of Phase 3 data. Consult a licensed clinician and do not attempt to source or self-administer this compound.

This is general research/context information, not medical advice or a recommended protocol.

Safety & side effects

Dose-dependent gastrointestinal adverse events are the primary safety signal: nausea (reported in up to 82% of highest-dose subcutaneous cohort), vomiting (up to 53%), and diarrhea (up to 41%)
AE severity characterized as mild-to-moderate in published trial reports; no serious AEs and no fatalities reported through Phase 1b/2a
Overall discontinuation rate was approximately 33% in the SC trial; notably, approximately 59% of dropouts were attributed to reasons unrelated to adverse events (consent withdrawal, protocol violations including recreational drug use)
Safety profile is consistent with known class effects of GLP-1 agonists and amylin agonists; no unexpected organ-system signals identified through early phase
Long-term safety, cardiovascular outcomes, rare event rates, and safety in special populations (renal/hepatic impairment, pregnancy, pediatric) are unknown pending Phase 3 data
Oral formulation pharmacokinetics and bioavailability have been demonstrated, but long-term oral safety data are extremely limited
As an investigational compound not yet FDA-approved, post-marketing safety data do not exist; all current safety knowledge derives from small early-phase trials

Drug & supplement interactions

Who should avoid it

Do not use outside of an enrolled, IRB-approved clinical trial - amycretin is not approved and has no legal commercial supply chain
Sources selling research-chemical amycretin cannot guarantee identity, purity, or sterility; Phase 3 safety data are absent
Avoid in individuals with personal or family history of medullary thyroid carcinoma or MEN2 syndrome (class concern carried from GLP-1 agonists, not yet specifically characterized for amycretin)
Avoid concurrent use with other GLP-1 agonists or amylin analogues without clinical supervision - combination effects are unstudied
Patients with severe gastrointestinal conditions (gastroparesis, active inflammatory bowel disease) should not self-administer given the prominent GI adverse event profile seen in early trials
Do not interpret early-phase weight loss percentages as predictive of personal outcomes - Phase 3 data are required to establish population-level efficacy

How it is commonly combined

No stacking data exist. Amycretin is being studied as monotherapy in all current trials. Combining with other GLP-1 agonists, GIP agonists, amylin analogues (such as pramlintide), or other investigational metabolic agents is entirely unstudied and carries unknown additive or adverse risk. No evidence-based stacking guidance can be offered for an investigational compound at this development stage.

Legal & regulatory. Not FDA-approved. Amycretin is an investigational new drug (IND) under active clinical development by Novo Nordisk. It is not legally available through any commercial, compounding, or direct-access channel in the United States. Phase 3 trials are anticipated to begin in 2026; an NDA submission is projected for 2027-2028 at the earliest. Any source offering amycretin outside of an enrolled clinical trial is operating outside regulatory bounds.

Quality & harm reduction

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Frequently asked questions

What makes amycretin different from semaglutide or tirzepatide?

Semaglutide is a GLP-1 receptor monoagonist. Tirzepatide is a dual GLP-1/GIP receptor agonist. Amycretin adds a second distinct mechanism - amylin receptor agonism - instead of GIP receptor agonism. Amylin acts primarily in the hindbrain (area postrema) on circuits distinct from the hypothalamic pathways central to GLP-1 signaling. The rationale is that combining GLP-1 and amylin mechanisms in a single molecule may produce additive or synergistic weight loss. Whether this translates to superior outcomes in Phase 3 head-to-head trials is not yet established.

Is amycretin available to patients today?

No. Amycretin is not FDA-approved and has no authorized commercial supply in the United States. It is available only within enrolled clinical trials. Compounds sold online as amycretin by research chemical vendors are not pharmaceutical-grade and are not the same product studied in clinical trials; their identity and safety are unverified.

What dose should I take?

Dosing information for amycretin cannot be provided. The compound is not approved for clinical use. Dose ranges reported in the literature are clinical trial protocol details, not prescribing information. Consult a licensed physician or endocrinologist; do not attempt to self-administer any form of this compound.

Is the 22% weight loss result reliable?

The 22% mean weight loss figure comes from the highest-dose cohort (20 mg weekly subcutaneous) in a Phase 1b/2a randomized controlled trial published in The Lancet (PMID 40550231), 36 weeks in duration. It is a real finding from a peer-reviewed trial. However, Phase 1b/2a trials are small, short, and enroll selected populations; results frequently do not fully replicate in larger Phase 3 programs. The figure should be understood as a signal of potential efficacy, not a definitive outcome. Phase 3 data are required for regulatory-grade efficacy conclusions.

When might amycretin be FDA-approved?

Phase 3 trials are anticipated to begin in 2026 for both obesity and type 2 diabetes. If trials complete on schedule and demonstrate required efficacy and safety, Novo Nordisk has projected an NDA submission in the 2027-2028 timeframe. Conditional commercial availability forecasts have centered on approximately 2030, but this is contingent on successful Phase 3 outcomes, regulatory review timelines, and manufacturing scale-up. None of these timelines are guaranteed.

What are the main side effects seen so far?

In Phase 1b/2a trials, dose-dependent gastrointestinal symptoms were the dominant adverse event category: nausea was reported in up to 82%, vomiting in up to 53%, and diarrhea in up to 41% of participants in the highest-dose subcutaneous cohorts. These events were characterized as mild-to-moderate in severity; no serious adverse events and no fatalities were reported through the completed early-phase program. The profile is consistent with GLP-1 and amylin agonist class effects. Long-term, rare-event, and special-population safety are unknown until Phase 3 data mature.

References & further reading

PubMed: amycretin phase 1b 2a subcutaneous randomized obesity weight loss Novo Nordisk (PMID 40550231)
PubMed: amycretin body weight metabolic dysfunction animal model mechanism (PMID 40706446)
PubMed: amycretin preclinical murine rat efficacy GLP-1 amylin dual agonist (PMC12309853)
ClinicalTrials.gov: NCT05369390 (oral amycretin Phase 1 first-in-human obesity)
ClinicalTrials.gov: NCT06064006 (subcutaneous amycretin Phase 1b/2a obesity); NCT06049329 (Japan obesity cohort)