NCT04667377

A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

A Phase II, Randomized, Double Blind, Parallel Group,46 Weeks Dose-finding Study of BI 456906 Administered Once Weekly Subcutaneously Compared With Placebo in Patients With Obesity or Overweight

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 387 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight. Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine. Participants are in the study for about a year. During this time, there are about 20 in-person visits to the study site. At the study site visits, doctors measure participants' body weight. Results are compared between the BI 456906 groups and the placebo group. The doctors also regularly check the general health of the participants.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	BI 456906	BI 456906
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-03-08
• Primary completion: 2022-09-15
• Completion: 2022-10-07
• First posted: 2020-12-14
• Last updated: 2023-11-02
• Results posted: 2023-11-02

Locations

43 sites across 12 countries: United States, Australia, Belgium, Canada, China, Germany, Netherlands, New Zealand, Poland, South Korea, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study