Study S002124

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 1820237 Alone (Trial Parts 1+2) or Together With a Low Dose of Liraglutide (Trial Part 3) in Otherwise Healthy Male Subjects With Overweight/Obesity (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

ClinicalTrials.gov record

Registration

Registration: NCT04903509
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: SINGLE
Status: COMPLETED
Enrollment: 95
Start: 2021-06-08
Primary completion: 2022-08-26
Lead sponsor: Boehringer Ingelheim
Conditions: Healthy
Interventions: DRUG:BI 1820237; DRUG:Placebo; DRUG:Saxenda®; DRUG:Paracetamol-ratiopharm®
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: EUDRACT_NUMBER:2021-000327-13

Registered primary outcomes

Percentage of subjects with drug-related adverse events [up to 48 days]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0011234	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, Diabetes, obesity & metabolism	2025	Randomized trial	PMID 39373311 DOI	cites ClinicalTrials.gov:NCT04903509