A randomized phase I study of BI 1820237, a novel neuropeptide Y receptor type 2 agonist, alone or in combination with low-dose liraglutide in otherwise healthy men with overweight or obesity.

Beetz N, Kalsch B, Forst T, Schmid B, Schultz A, Hennige AM

Diabetes, obesity & metabolism7 Oct 2024Cited by 9 (Europe PMC)

PMID39373311DOI10.1111/dom.15984PepBankPUB-39373311

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 study4

1 result from studies that gave the peptide. 1 result from people.

01HumanRandomized controlled trialSafety outcome
In healthy men with overweight or obesity, one drug-related adverse event was reported in a participant receiving placebo plus liraglutide.
In plain wordsIn healthy men with overweight or obesity, one placebo-plus-liraglutide recipient had a drug-related side effect, reported as 11.1%.
Peptide
Liraglutide
Outcome
Not applicableDrug-related adverse event with liraglutide
Study
n: not reported in source
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
0.6 mgAs given in this study (human).
Measurements
Drug-related adverse events
11.1%
placebo plus liraglutide
Participants with drug-related adverse events
1 participant
placebo plus liraglutide
Source sentences
Summary
Drug-related AEs, mainly gastrointestinal events, were reported by 39.0% of participants (n = 23) in parts 1 + 2 and 30.6% of participants (n = 11) in part 3; one drug-related AE (11.1%, part 3) was reported in a participant receiving placebo with liraglutide.
3 context sentences(design, population, supporting numbers)
Summary · context
part 3 (BI 1820237: 0.025-1.2 mg + liraglutide 0.6 mg or placebo + liraglutide 0.6 mg).
Summary · context
Primary endpoint is the proportion of participants with drug-related AEs.
Summary · context
In total, 95 otherwise healthy men with increased BMI (25.0-34.9 kg/m²) were randomized.
Report a problemFND-3937331102

Studies that did not test the peptide alone3

In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Liraglutide.

02HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In otherwise healthy men with overweight or obesity, pooled part-3 BI 1820237-plus-liraglutide and placebo-plus-liraglutide regimens had drug-related adverse events in 30.6% (11 participants).
In plain wordsIn healthy men with overweight or obesity, pooled part-3 regimens including liraglutide had drug-related side effects in 30.6%.
Peptide
Liraglutide
Outcome
Not applicableDrug-related adverse events in pooled part-3 regimens
Study
n: not reported in source
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Participants with drug-related adverse events
30.6%
pooled part-3 BI 1820237 plus liraglutide or placebo plus liraglutide
Participants with drug-related adverse events
11 participants
pooled part 3; denominator not reported
Source sentences
Summary
Drug-related AEs, mainly gastrointestinal events, were reported by 39.0% of participants (n = 23) in parts 1 + 2 and 30.6% of participants (n = 11) in part 3; one drug-related AE (11.1%, part 3) was reported in a participant receiving placebo with liraglutide.
3 context sentences(design, population, supporting numbers)
Summary · context
part 3 (BI 1820237: 0.025-1.2 mg + liraglutide 0.6 mg or placebo + liraglutide 0.6 mg).
Summary · context
Primary endpoint is the proportion of participants with drug-related AEs.
Summary · context
In total, 95 otherwise healthy men with increased BMI (25.0-34.9 kg/m²) were randomized.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-3937331101
03HumanNot a test of Liraglutide aloneRandomized controlled trialMechanism
In otherwise healthy men with overweight or obesity, post-dose paracetamol pharmacokinetics suggested additive effects of BI 1820237 and low-dose liraglutide on gastric emptying; direction was unspecified.
In plain wordsIn healthy men with overweight or obesity, BI 1820237 plus liraglutide showed suggested additive effects on stomach emptying; direction was unspecified.
Peptide
Liraglutide
Outcome
Direction not reportedGastric emptying
Study
n: not reported in source
Analysis
Secondary
Outcome group
Receptor activity and mechanism · Gastrointestinal
Source sentences
Summary
Post-dose paracetamol PK suggested that BI 1820237 and low-dose liraglutide exhibited additive effects on gastric emptying.
3 context sentences(design, population, supporting numbers)
Summary · context
part 3 (BI 1820237: 0.025-1.2 mg + liraglutide 0.6 mg or placebo + liraglutide 0.6 mg).
Summary · context
Secondary endpoints are tolerability, PK and PD.
Summary · context
In total, 95 otherwise healthy men with increased BMI (25.0-34.9 kg/m²) were randomized.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-3937331103
04HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In otherwise healthy men with overweight or obesity, drug-related adverse events were mainly gastrointestinal across studied regimens, including liraglutide-containing part 3; the native-specific gastrointestinal rate was unstated.
In plain wordsIn healthy men with overweight or obesity, drug-related side effects were mainly gastrointestinal across studied regimens, including ones containing liraglutide.
Peptide
Liraglutide
Outcome
Not applicableGastrointestinal drug-related adverse events across studied regimens
Study
n: not reported in source
Outcome group
Adverse events · Gastrointestinal
Source sentences
Summary
Drug-related AEs, mainly gastrointestinal events, were reported by 39.0% of participants (n = 23) in parts 1 + 2 and 30.6% of participants (n = 11) in part 3; one drug-related AE (11.1%, part 3) was reported in a participant receiving placebo with liraglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
part 3 (BI 1820237: 0.025-1.2 mg + liraglutide 0.6 mg or placebo + liraglutide 0.6 mg).
Summary · context
In total, 95 otherwise healthy men with increased BMI (25.0-34.9 kg/m²) were randomized.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-3937331104

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

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
12 Oct 2026, 11:11 UTC
Study results updated
Version 1
9 Oct 2026, 03:04 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.