Skip to main content
🧬Peptide Protocol Wiki

Amycretin: Research & Studies

Scientific evidence, clinical trials, and research findings

Evidence Level: moderate
✓Reviewed byDr. Research Team(MD (composite credential representing medical review team), PhD in Pharmacology)
📅Updated February 12, 2026
Verified

📌TL;DR

  • •3 clinical studies cited
  • •Overall evidence level: moderate
  • •8 research gaps identified
Evidence pyramid for Amycretin research
Overview of evidence quality and study types

Research Studies

Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study

Dahl K, Toubro S, Dey S, et al. (2025) • The Lancet

PubMed

Phase 1b/2a trial of once-weekly SC amycretin in 125 participants with overweight or obesity over up to 36 weeks. Demonstrated dose-dependent weight loss up to 24.3% at 60 mg.

Key Findings

  • 60 mg dose: 24.3% weight loss at 36 weeks vs 1.1% placebo
  • 20 mg dose: 22.0% weight loss at 36 weeks
  • 5 mg dose: 16.2% weight loss at 28 weeks
  • 1.25 mg dose: 9.7% weight loss at 20 weeks
  • No weight loss plateau observed at higher doses
  • GI adverse events most common, majority mild to moderate
  • Nausea 82%, vomiting 53%, diarrhea 41%
  • 33% discontinued (59% of discontinuations unrelated to AEs)

Limitations: Single-center study (San Antonio, TX)Small sample size (125 participants)33% overall discontinuation rateNo active comparator arm

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

Novo Nordisk investigators (2025) • The Lancet

PubMed

First-in-human Phase 1 trial of oral and SC amycretin in 144 participants. Oral amycretin (with SNAC) achieved up to 13.1% weight loss at 12 weeks.

Key Findings

  • Oral 2x50 mg: 13.1% weight loss at 12 weeks vs 1.2% placebo
  • Oral 50 mg: 10.4% weight loss at 12 weeks
  • 364 TEAEs in 89 (62%) of 144 participants
  • All TEAEs were mild or moderate in severity
  • 49% of all TEAEs were gastrointestinal
  • No deaths reported

Limitations: Short 12-week treatment duration for oral formulationSingle-center studyPhase 1 trial (not powered for efficacy)

Phase 2 Trial of Amycretin in Type 2 Diabetes

Novo Nordisk (2025) • Novo Nordisk press release

Phase 2 trial of SC and oral amycretin in 448 patients with T2D inadequately controlled on metformin over 36 weeks.

Key Findings

  • SC amycretin: up to 14.5% weight loss at 36 weeks (vs 2.6% placebo)
  • Oral amycretin: up to 10.1% weight loss at 36 weeks (vs 2.5% placebo)
  • SC HbA1c reduction: up to 1.8% from baseline 7.8%
  • Oral HbA1c reduction: up to 1.5% from baseline 8.0%
  • SC: up to 89.1% achieved HbA1c <7%, 76.2% achieved HbA1c <=6.5%
  • No plateau at higher doses over 36 weeks
  • Safe and well-tolerated profile consistent with incretin and amylin therapies

Limitations: Full peer-reviewed publication pendingNo active comparator arm36-week duration may not capture long-term outcomes

Unlock full research citations

Free access to all clinical studies, citations, and evidence summaries.

150+ peptide profiles · 30+ comparisons · 18 research tools

Already subscribed?
Research timeline for Amycretin
Key studies and discoveries over time

Community Experience Data

See how community outcomes align with (or diverge from) the research findings above.

0View community protocols

Explore research gaps across all peptides → | View clinical trial pipeline →

🔍Research Gaps & Future Directions

  • •Phase 3 data not yet available (planned 2026 for obesity and T2D)
  • •No head-to-head comparisons with semaglutide, CagriSema, or tirzepatide
  • •Cardiovascular outcomes data not available
  • •Long-term safety beyond 36 weeks not characterized
  • •Oral formulation efficacy in obesity over longer duration not tested
  • •Weight maintenance after treatment discontinuation unknown
  • •Detailed receptor binding profiles not fully published
  • •Effect on body composition (lean mass preservation) not characterized

Research Overview#

Amycretin has been characterized through three key clinical datasets: a Phase 1 first-in-human trial of oral formulation, a Phase 1b/2a trial of subcutaneous formulation in obesity, and a Phase 2 trial in type 2 diabetes. Two publications in The Lancet (PMIDs 40550229 and 40550231) provide the primary evidence base. The subcutaneous formulation achieved up to 24.3% weight loss at 36 weeks, among the highest reported for any single-molecule anti-obesity therapy.

Lancet Publication: Phase 1b/2a Subcutaneous (PMID 40550231)#

Study Design#

  • Phase 1b/2a, randomized, placebo-controlled, double-blind
  • Single center (San Antonio, TX)
  • 125 participants with overweight or obesity (BMI 27.0-39.9)
  • Enrolled September 2023 to April 2024
  • Authors: Dahl K, Toubro S, Dey S, et al.

Key Efficacy Results#

DoseDurationWeight Lossvs Placebo
1.25 mg20 weeks-9.7%vs -2.0%
5 mg28 weeks-16.2%vs -2.3%
20 mg36 weeks-22.0%vs -1.9%
60 mg36 weeks-24.3%vs -1.1%

No weight loss plateau was observed at the higher doses, suggesting continued weight loss with longer treatment.

Safety#

  • Most common TEAEs were GI (nausea 82%, vomiting 53%, diarrhea 41%)
  • GI events peaked during up-titration and diminished thereafter
  • Nearly all TEAEs mild to moderate
  • 33% overall discontinuation rate (59% of discontinuations unrelated to AEs)
  • No serious safety signals

Lancet Publication: Phase 1 Oral (PMID 40550229)#

Study Design#

  • Phase 1, first-in-human, randomized, double-blind, placebo-controlled
  • 144 participants in four parts (A-D)
  • Oral formulation with SNAC permeation enhancer

Key Results#

  • Oral 50 mg: 10.4% weight loss at 12 weeks
  • Oral 2x50 mg: 13.1% weight loss at 12 weeks
  • 62% of participants reported TEAEs (all mild or moderate)
  • 49% of TEAEs were GI-related
  • No deaths or serious safety concerns

Phase 2 in Type 2 Diabetes#

Study Design#

  • 448 patients with T2D inadequately controlled on metformin
  • Both SC and oral formulations evaluated over 36 weeks
  • Multiple dose cohorts

Key Results#

  • SC weight loss: Up to 14.5% (vs 2.6% placebo)
  • Oral weight loss: Up to 10.1% (vs 2.5% placebo)
  • SC HbA1c: Up to -1.8% from baseline 7.8%
  • Oral HbA1c: Up to -1.5% from baseline 8.0%
  • 89.1% of SC patients achieved HbA1c <7%
  • No plateau at higher doses

Evidence Quality Assessment#

The evidence base is moderate:

Strengths:

  • Two Lancet publications (high-impact journal)
  • Consistent dose-response across trials
  • Both obesity and T2D data
  • Both SC and oral formulations demonstrated efficacy
  • Novel first-in-class mechanism

Limitations:

  • Phase 1-2 data only; Phase 3 not yet initiated
  • Single-center design for obesity trials
  • Relatively small sample sizes
  • 33% discontinuation rate in Phase 1b/2a
  • No active comparator
  • No CV outcomes data

Research Gaps#

  1. Phase 3 validation: Pivotal trial data needed for both indications
  2. Head-to-head comparisons: No trials vs CagriSema, semaglutide, or tirzepatide
  3. Cardiovascular outcomes: No CVOT planned or available
  4. Long-term safety: Beyond 36 weeks not characterized
  5. Oral formulation: Longer-term obesity data needed
  6. Weight regain: Post-discontinuation trajectory unknown
  7. Body composition: Lean mass effects not characterized

Frequently Asked Questions About Amycretin

Explore Further

Calculate your dose

Reconstitution volumes, injection doses, and supply planning

Explore the evidence

Filter and sort clinical studies across all peptides

⚠️

Medical Disclaimer

This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.

CompareToolsVendors