CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 387 enrolled
Drug / intervention
BI 456906 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04667377
NCT04667377Phase 2Completed

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

Boehringer Ingelheim·interventional·Posted Dec 14, 2020·Updated Nov 2, 2023

In Brief

A Phase 2 clinical trial evaluating BI 456906 and Placebo for Obesity. Completed, enrolled 387 participants across 43 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesAustralia, Belgium, Canada, China, Germany, Netherlands, New Zealand, Poland, South Korea, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 14, 2020
Enrollment StartMar 8, 2021
Primary CompletionSep 15, 2022
Study CompletionOct 7, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.5 years ago

Interventions

BI 456906drug

BI 456906

Placebodrug

Placebo