Efficacy and safety of once-weekly subcutaneous zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial.

Mora P, Aroda VR, Asong M, Blüher M, Heftdal LD, Carlander AF, Vilsen LN, Rosenstock J

Lancet (London, England)30 Jul 2026

PMID42532080DOI10.1016/s0140-6736(26)01248-1PepBankPUB-42532080

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, zenagamtide 0·4 mg changed HbA1c by -0·9% at week 36, with a placebo-adjusted difference of -0·77%.
In plain wordsIn adults with type 2 diabetes, zenagamtide at 0·4 mg lowered HbA1c more than placebo at week 36.
Peptide
Amycretin
Outcome
DecreaseHbA1c change at 0·4 mg
Study
n = 75
Comparator
placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0·4 mg · subcutaneous · 36 weeksAs given in this study (human).
Measurements
HbA1c change from baseline at week 36
−0.9%
zenagamtide 0.4 mg
Estimated treatment difference vs placebo
−0.77%
zenagamtide 0.4 mg, 95% CI -1.26 to -0.28
95% CI of treatment difference
−1.26 to −0.28%
zenagamtide 0.4 mg vs placebo
Source sentences
Summary
At week 36, estimated change in HbA_1c (mean across all groups at baseline 7·8% [SD 0·8]) ranged from -0·9% with zenagamtide 0·4 mg (estimated treatment difference vs placebo: -0·77% [95% CI -1·26 to -0·28]; p=0·0021) to -1·7% with zenagamtide 40 mg (-1·56% [-2·05 to -1·07]; p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
This 36-week, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial was conducted at 83 hospital and clinic sites across 11 countries.
Report a problemFND-4253208001
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, zenagamtide 40 mg changed HbA1c by -1·7% at week 36, with a placebo-adjusted difference of -1·56%.
In plain wordsIn adults with type 2 diabetes, zenagamtide at 40 mg lowered HbA1c more than placebo at week 36.
Peptide
Amycretin
Outcome
DecreaseHbA1c change at 40 mg
Study
n = 75
Comparator
placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
40 mg · subcutaneous · 36 weeksAs given in this study (human).
Measurements
HbA1c change from baseline at week 36
−1.7%
zenagamtide 40 mg
Estimated treatment difference vs placebo
−1.56%
zenagamtide 40 mg, 95% CI -2.05 to -1.07
95% CI of treatment difference
−2.05 to −1.07%
zenagamtide 40 mg vs placebo
Source sentences
Summary
At week 36, estimated change in HbA_1c (mean across all groups at baseline 7·8% [SD 0·8]) ranged from -0·9% with zenagamtide 0·4 mg (estimated treatment difference vs placebo: -0·77% [95% CI -1·26 to -0·28]; p=0·0021) to -1·7% with zenagamtide 40 mg (-1·56% [-2·05 to -1·07]; p<0·0001).
2 context sentences(design, population, supporting numbers)
Summary · context
This 36-week, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial was conducted at 83 hospital and clinic sites across 11 countries.
Summary · context
Participants were further randomly assigned (1:1:1:1:1:1) to one of six doses (38 participants to 0·4 mg, 36 participants to 1·5 mg, 37 participants to 5 mg, 38 participants to 10 mg, 38 participants to 20 mg, and 38 participants to 40 mg) or placebo (37 participants).
Report a problemFND-4253208009
03HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, four zenagamtide recipients reported serious adverse events at 0·4 mg.
In plain wordsIn adults with type 2 diabetes, four people receiving zenagamtide at 0·4 mg reported serious adverse events.
Peptide
Amycretin
Outcome
Not applicableSerious adverse events at 0·4 mg
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
0·4 mg · subcutaneous · 36 weeksAs given in this study (human).
Measurements
Participants with serious adverse events
4 participants
zenagamtide 0.4 mg
Source sentences
Summary
21 (8%) of 261 participants reported serious adverse events (four with zenagamtide 0·4 mg, three with 1·5 mg, two with 5 mg, five with 10 mg, three with 20 mg, one with 40 mg, and three with placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
This 36-week, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial was conducted at 83 hospital and clinic sites across 11 countries.
Report a problemFND-4253208002
04HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, three zenagamtide recipients reported serious adverse events at 1·5 mg.
In plain wordsIn adults with type 2 diabetes, three people receiving zenagamtide at 1·5 mg reported serious adverse events.
Peptide
Amycretin
Outcome
Not applicableSerious adverse events at 1·5 mg
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
1·5 mg · subcutaneous · 36 weeksAs given in this study (human).
Measurements
Participants with serious adverse events
3 participants
zenagamtide 1.5 mg
Source sentences
Summary
21 (8%) of 261 participants reported serious adverse events (four with zenagamtide 0·4 mg, three with 1·5 mg, two with 5 mg, five with 10 mg, three with 20 mg, one with 40 mg, and three with placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
This 36-week, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial was conducted at 83 hospital and clinic sites across 11 countries.
Report a problemFND-4253208003
05HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, two zenagamtide recipients reported serious adverse events at 5 mg.
In plain wordsIn adults with type 2 diabetes, two people receiving zenagamtide at 5 mg reported serious adverse events.
Peptide
Amycretin
Outcome
Not applicableSerious adverse events at 5 mg
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
5 mg · subcutaneous · 36 weeksAs given in this study (human).
Measurements
Participants with serious adverse events
2 participants
zenagamtide 5 mg
Source sentences
Summary
21 (8%) of 261 participants reported serious adverse events (four with zenagamtide 0·4 mg, three with 1·5 mg, two with 5 mg, five with 10 mg, three with 20 mg, one with 40 mg, and three with placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
This 36-week, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial was conducted at 83 hospital and clinic sites across 11 countries.
Report a problemFND-4253208004
06HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, five zenagamtide recipients reported serious adverse events at 10 mg.
In plain wordsIn adults with type 2 diabetes, five people receiving zenagamtide at 10 mg reported serious adverse events.
Peptide
Amycretin
Outcome
Not applicableSerious adverse events at 10 mg
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
10 mg · subcutaneous · 36 weeksAs given in this study (human).
Measurements
Participants with serious adverse events
5 participants
zenagamtide 10 mg
Source sentences
Summary
21 (8%) of 261 participants reported serious adverse events (four with zenagamtide 0·4 mg, three with 1·5 mg, two with 5 mg, five with 10 mg, three with 20 mg, one with 40 mg, and three with placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
This 36-week, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial was conducted at 83 hospital and clinic sites across 11 countries.
Report a problemFND-4253208005
07HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, three zenagamtide recipients reported serious adverse events at 20 mg.
In plain wordsIn adults with type 2 diabetes, three people receiving zenagamtide at 20 mg reported serious adverse events.
Peptide
Amycretin
Outcome
Not applicableSerious adverse events at 20 mg
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
20 mg · subcutaneous · 36 weeksAs given in this study (human).
Measurements
Participants with serious adverse events
3 participants
zenagamtide 20 mg
Source sentences
Summary
21 (8%) of 261 participants reported serious adverse events (four with zenagamtide 0·4 mg, three with 1·5 mg, two with 5 mg, five with 10 mg, three with 20 mg, one with 40 mg, and three with placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
This 36-week, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial was conducted at 83 hospital and clinic sites across 11 countries.
Report a problemFND-4253208006
08HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, one zenagamtide recipient reported a serious adverse event at 40 mg.
In plain wordsIn adults with type 2 diabetes, one person receiving zenagamtide at 40 mg reported a serious adverse event.
Peptide
Amycretin
Outcome
Not applicableSerious adverse events at 40 mg
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
40 mg · subcutaneous · 36 weeksAs given in this study (human).
Measurements
Participants with serious adverse events
1 participants
zenagamtide 40 mg
Source sentences
Summary
21 (8%) of 261 participants reported serious adverse events (four with zenagamtide 0·4 mg, three with 1·5 mg, two with 5 mg, five with 10 mg, three with 20 mg, one with 40 mg, and three with placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
This 36-week, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial was conducted at 83 hospital and clinic sites across 11 countries.
Report a problemFND-4253208007
09HumanRandomized controlled trialSafety outcome
In the zenagamtide trial, no deaths occurred.
In plain wordsIn the zenagamtide trial, no participants died.
Peptide
Amycretin
Outcome
Not applicableDeaths
Study
n: not reported in source
Outcome group
Mortality · Whole body
Studied dose
Dose not stated · subcutaneous · 36 weeksAs given in this study (human).
Source sentences
Summary
No deaths occurred.
1 context sentence(design, population, supporting numbers)
Summary · context
This 36-week, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial was conducted at 83 hospital and clinic sites across 11 countries.
Report a problemFND-4253208008

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT06542874

A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes

Novo Nordisk A/Sn = 4487 Aug 2024 to 24 Oct 2025

Type 2 Diabetes (T2D)

Trial page ClinicalTrials.govUpdated 2 Oct 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
27 Oct 2026, 18:20 UTC
Study results updated
Version 1
27 Oct 2026, 16:32 UTC
First added · source update from Europe PMC

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