Petrelintide, a human amylin analogue for the treatment of obesity (ZUPREME 1): a randomised, double-blind, placebo-controlled, phase 2 trial.

Garvey WT, Ard J, Connery L, Frias JP, le Roux CW, Pietiläinen KH, Dinesen M, Hagen BF, Larsen L, Hesse D, Kendall DM

The lancet. Diabetes & endocrinology29 Sept 2026

PMID42810355DOI10.1016/s2213-8587(26)00213-5PepBankPUB-42810355

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 study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In eligible adults with overweight or obesity, petrelintide 5·0 mg reduced bodyweight by 9·8% versus 1·7% with placebo at 28 weeks.
In plain wordsIn adults with overweight or obesity, weight decreased 9·8% with petrelintide 5·0 mg versus 1·7% with placebo at 28 weeks.
Peptide
Petrelintide
Outcome
DecreaseBodyweight change at 28 weeks, 5·0 mg
Study
n = 164
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
5·0 mg once weekly · subcutaneous · 28 weeksAs given in this study (human).
Measurements
Bodyweight change from baseline at 28 weeks
−9.8%
petrelintide 5·0 mg
Bodyweight change from baseline at 28 weeks (95% CI)
−10.9 to −8.6%
petrelintide 5·0 mg
Bodyweight change from baseline at 28 weeks
−1.7%
placebo
Bodyweight change from baseline at 28 weeks (95% CI)
−2.8 to −0.5%
placebo
Estimated treatment difference versus placebo
−8.1%
petrelintide 5·0 mg
Estimated treatment difference versus placebo (95% CI)
−9.7 to −6.5%
petrelintide 5·0 mg
Source sentences
Summary
-9·8% (-10·9 to -8·6) with petrelintide 5·0 mg
4 context sentences(design, population, supporting numbers)
Summary · context
versus -1·7% (-2·8 to -0·5) with placebo.
Summary · context
-8·1% (-9·7 to -6·5) with petrelintide 5·0 mg
Summary · context
This phase 2 trial aimed to evaluate the efficacy and safety of once-weekly petrelintide versus placebo in people with obesity.
Summary · context
Analyses included all randomly assigned participants who received at least one dose.
Report a problemFND-4281035503
02HumanRandomized controlled trialEfficacy outcome
In eligible adults with overweight or obesity, petrelintide 9·0 mg reduced bodyweight by 9·4% versus 1·7% with placebo at 28 weeks.
In plain wordsIn adults with overweight or obesity, weight decreased 9·4% with petrelintide 9·0 mg versus 1·7% with placebo at 28 weeks.
Peptide
Petrelintide
Outcome
DecreaseBodyweight change at 28 weeks, 9·0 mg
Study
n = 163
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
9·0 mg once weekly · subcutaneous · 28 weeksAs given in this study (human).
Measurements
Bodyweight change from baseline at 28 weeks
−9.4%
petrelintide 9·0 mg
Bodyweight change from baseline at 28 weeks (95% CI)
−10.5 to −8.3%
petrelintide 9·0 mg
Bodyweight change from baseline at 28 weeks
−1.7%
placebo
Bodyweight change from baseline at 28 weeks (95% CI)
−2.8 to −0.5%
placebo
Estimated treatment difference versus placebo
−7.7%
petrelintide 9·0 mg
Estimated treatment difference versus placebo (95% CI)
−9.4 to −6.1%
petrelintide 9·0 mg
Source sentences
Summary
-9·4% (-10·5 to -8·3) with petrelintide 9·0 mg versus -1·7% (-2·8 to -0·5) with placebo.
3 context sentences(design, population, supporting numbers)
Summary · context
and -7·7% (-9·4 to -6·1) with petrelintide 9·0 mg.
Summary · context
This phase 2 trial aimed to evaluate the efficacy and safety of once-weekly petrelintide versus placebo in people with obesity.
Summary · context
Analyses included all randomly assigned participants who received at least one dose.
Report a problemFND-4281035505
03HumanRandomized controlled trialEfficacy outcome
In eligible adults with overweight or obesity, petrelintide 2·5 mg reduced bodyweight by 7·9% versus 1·7% with placebo at 28 weeks.
In plain wordsIn adults with overweight or obesity, weight decreased 7·9% with petrelintide 2·5 mg versus 1·7% with placebo at 28 weeks.
Peptide
Petrelintide
Outcome
DecreaseBodyweight change at 28 weeks, 2·5 mg
Study
n = 162
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
2·5 mg once weekly · subcutaneous · 28 weeksAs given in this study (human).
Measurements
Bodyweight change from baseline at 28 weeks
−7.9%
petrelintide 2·5 mg
Bodyweight change from baseline at 28 weeks (95% CI)
−9 to −6.7%
petrelintide 2·5 mg
Bodyweight change from baseline at 28 weeks
−1.7%
placebo
Bodyweight change from baseline at 28 weeks (95% CI)
−2.8 to −0.5%
placebo
Estimated treatment difference versus placebo
−6.2%
petrelintide 2·5 mg
Estimated treatment difference versus placebo (95% CI)
−7.8 to −4.5%
petrelintide 2·5 mg
Source sentences
Summary
-7·9% (-9·0 to -6·7) with petrelintide 2·5 mg
4 context sentences(design, population, supporting numbers)
Summary · context
versus -1·7% (-2·8 to -0·5) with placebo.
Summary · context
-6·2% (-7·8 to -4·5) with petrelintide 2·5 mg
Summary · context
This phase 2 trial aimed to evaluate the efficacy and safety of once-weekly petrelintide versus placebo in people with obesity.
Summary · context
Analyses included all randomly assigned participants who received at least one dose.
Report a problemFND-4281035502
04HumanRandomized controlled trialEfficacy outcome
In eligible adults with overweight or obesity, petrelintide 1·0 mg reduced bodyweight by 7·9% versus 1·7% with placebo at 28 weeks.
In plain wordsIn adults with overweight or obesity, weight decreased 7·9% with petrelintide 1·0 mg versus 1·7% with placebo at 28 weeks.
Peptide
Petrelintide
Outcome
DecreaseBodyweight change at 28 weeks, 1·0 mg
Study
n = 160
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
1·0 mg once weekly · subcutaneous · 28 weeksAs given in this study (human).
Measurements
Bodyweight change from baseline at 28 weeks
−7.9%
petrelintide 1·0 mg
Bodyweight change from baseline at 28 weeks (95% CI)
−9 to −6.7%
petrelintide 1·0 mg
Bodyweight change from baseline at 28 weeks
−1.7%
placebo
Bodyweight change from baseline at 28 weeks (95% CI)
−2.8 to −0.5%
placebo
Estimated treatment difference versus placebo
−6.2%
petrelintide 1·0 mg
Estimated treatment difference versus placebo (95% CI)
−7.9 to −4.5%
petrelintide 1·0 mg
Source sentences
Summary
Mean percentage change in bodyweight from baseline after 28 weeks (efficacy estimand) was -7·9% (95% CI -9·0 to -6·7) with petrelintide 1·0 mg
4 context sentences(design, population, supporting numbers)
Summary · context
versus -1·7% (-2·8 to -0·5) with placebo.
Summary · context
Estimated treatment differences versus placebo were -6·2% (-7·9 to -4·5) with petrelintide 1·0 mg
Summary · context
This phase 2 trial aimed to evaluate the efficacy and safety of once-weekly petrelintide versus placebo in people with obesity.
Summary · context
Analyses included all randomly assigned participants who received at least one dose.
Report a problemFND-4281035501
05HumanRandomized controlled trialEfficacy outcome
In eligible adults with overweight or obesity, petrelintide 7·0 mg reduced bodyweight by 9·3% versus 1·7% with placebo at 28 weeks.
In plain wordsIn adults with overweight or obesity, weight decreased 9·3% with petrelintide 7·0 mg versus 1·7% with placebo at 28 weeks.
Peptide
Petrelintide
Outcome
DecreaseBodyweight change at 28 weeks, 7·0 mg
Study
n = 160
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
7·0 mg once weekly · subcutaneous · 28 weeksAs given in this study (human).
Measurements
Bodyweight change from baseline at 28 weeks
−9.3%
petrelintide 7·0 mg
Bodyweight change from baseline at 28 weeks (95% CI)
−10.5 to −8.2%
petrelintide 7·0 mg
Bodyweight change from baseline at 28 weeks
−1.7%
placebo
Bodyweight change from baseline at 28 weeks (95% CI)
−2.8 to −0.5%
placebo
Estimated treatment difference versus placebo
−7.7%
petrelintide 7·0 mg
Estimated treatment difference versus placebo (95% CI)
−9.3 to −6%
petrelintide 7·0 mg
Source sentences
Summary
-9·3% (-10·5 to -8·2) with petrelintide 7·0 mg
4 context sentences(design, population, supporting numbers)
Summary · context
versus -1·7% (-2·8 to -0·5) with placebo.
Summary · context
-7·7% (-9·3 to -6·0) with petrelintide 7·0 mg
Summary · context
This phase 2 trial aimed to evaluate the efficacy and safety of once-weekly petrelintide versus placebo in people with obesity.
Summary · context
Analyses included all randomly assigned participants who received at least one dose.
Report a problemFND-4281035504
06HumanRandomized controlled trialSafety outcome
In eligible adults with overweight or obesity, nausea occurred in 79 of 404 petrelintide recipients (20%) versus five placebo recipients (6%).
In plain wordsIn adults with overweight or obesity, nausea occurred in 20% with petrelintide versus 6% with placebo.
Peptide
Petrelintide
Outcome
IncreaseNausea
Study
n = 485
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Nausea incidence
20%
petrelintide (79 of 404)
Nausea incidence
6%
placebo (5 participants)
Source sentences
Summary
The most common adverse event with petrelintide was nausea (79 [20%] of 404 participants vs five [6%] participants with placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 2 trial aimed to evaluate the efficacy and safety of once-weekly petrelintide versus placebo in people with obesity.
Summary · context
Analyses included all randomly assigned participants who received at least one dose.
Report a problemFND-4281035507
07HumanRandomized controlled trialSafety outcome
In eligible adults with overweight or obesity, vomiting occurred in 12 petrelintide recipients (3%) versus five placebo recipients (6%).
In plain wordsIn adults with overweight or obesity, vomiting occurred in 3% with petrelintide versus 6% with placebo.
Peptide
Petrelintide
Outcome
DecreaseVomiting
Study
n = 485
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Vomiting incidence
3%
petrelintide (12 participants)
Vomiting incidence
6%
placebo (5 participants)
Source sentences
Summary
Vomiting was infrequent with petrelintide (12 [3%] participants vs five [6%] with placebo)
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 2 trial aimed to evaluate the efficacy and safety of once-weekly petrelintide versus placebo in people with obesity.
Summary · context
Analyses included all randomly assigned participants who received at least one dose.
Report a problemFND-4281035508
08HumanRandomized controlled trialSafety outcome
In eligible adults with overweight or obesity, diarrhoea rates were similarly low with petrelintide (30 participants, 7%) and placebo (six participants, 7%).
In plain wordsIn adults with overweight or obesity, diarrhoea occurred in 7% with petrelintide and 7% with placebo.
Peptide
Petrelintide
Outcome
No significant changeDiarrhoea
Study
n = 485
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Diarrhoea incidence
7%
petrelintide (30 participants)
Diarrhoea incidence
7%
placebo (6 participants)
Source sentences
Summary
active treatment and placebo had similarly low rates for diarrhoea (30 [7%] participants vs six [7%] with placebo)
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 2 trial aimed to evaluate the efficacy and safety of once-weekly petrelintide versus placebo in people with obesity.
Summary · context
Analyses included all randomly assigned participants who received at least one dose.
Report a problemFND-4281035509
09HumanRandomized controlled trialSafety outcome
In eligible adults with overweight or obesity, constipation rates were similarly low with petrelintide (28 participants, 7%) and placebo (three participants, 4%).
In plain wordsIn adults with overweight or obesity, constipation occurred in 7% with petrelintide versus 4% with placebo.
Peptide
Petrelintide
Outcome
No significant changeConstipation
Study
n = 485
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Constipation incidence
7%
petrelintide (28 participants)
Constipation incidence
4%
placebo (3 participants)
Source sentences
Summary
active treatment and placebo had similarly low rates for diarrhoea (30 [7%] participants vs six [7%] with placebo) and constipation (28 [7%] vs three [4%] with placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 2 trial aimed to evaluate the efficacy and safety of once-weekly petrelintide versus placebo in people with obesity.
Summary · context
Analyses included all randomly assigned participants who received at least one dose.
Report a problemFND-4281035510
10HumanRandomized controlled trialSafety outcome
In the obesity trial, no deaths were reported, including during petrelintide treatment.
In plain wordsIn the obesity trial, no deaths were reported, including during petrelintide treatment.
Peptide
Petrelintide
Outcome
Not applicableDeaths
Study
n = 404
Outcome group
Mortality · Whole body
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
No deaths were reported.
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 2 trial aimed to evaluate the efficacy and safety of once-weekly petrelintide versus placebo in people with obesity.
Summary · context
Analyses included all randomly assigned participants who received at least one dose.
Report a problemFND-4281035511
11HumanRandomized controlled trialEfficacy outcome
In eligible adults with overweight or obesity, bodyweight continued to decline to week 42, with reductions up to -10·7% with petrelintide.
In plain wordsIn adults with overweight or obesity, weight continued to decrease to week 42, with reductions up to -10·7% with petrelintide.
Peptide
Petrelintide
Outcome
DecreaseBodyweight change through week 42
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · subcutaneous · 42 weeksAs given in this study (human).
Measurements
Bodyweight reduction through week 42
−10.7%
largest reported reduction with petrelintide, 'up to'
Source sentences
Summary
Bodyweight continued to decline to week 42, with reductions of up to -10·7% with petrelintide.
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 2 trial aimed to evaluate the efficacy and safety of once-weekly petrelintide versus placebo in people with obesity.
Summary · context
Analyses included all randomly assigned participants who received at least one dose.
Report a problemFND-4281035506

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 2NCT06662539

Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities

Zealand Pharman = 4939 Dec 2024 to 7 Mar 2026

Obesity

Trial page ClinicalTrials.govUpdated 23 Mar 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

Subjects

Terms as the source lists them.

Publication types

MeSH terms

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