NCT04903509

A Study in Men With Overweight to Test How Well Different Doses of BI 1820237 Are Tolerated When Given as an Injection Alone or in Combination With Liraglutide

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to investigate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1820237 alone or together with a single low dose of liraglutide in male subjects with overweight/obesity (otherwise healthy) following subcutaneous administration of single rising doses.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1820237	BI 1820237
DRUG	Placebo	Placebo
DRUG	Saxenda®	Saxenda®
DRUG	Paracetamol-ratiopharm®	Paracetamol-ratiopharm®

Timeline

• Start date: 2021-06-08
• Primary completion: 2022-08-26
• Completion: 2022-08-26
• First posted: 2021-05-26
• Last updated: 2022-08-31

Locations

1 site across 1 country: Germany