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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
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Diablo Clinical Research
Walnut Creek, California, United States
L-MARC Research Center
Louisville, Kentucky, United States
Lucas Research, Inc.
Morehead City, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Valley Weight Loss Clinic
Fargo, North Dakota, United States
Velocity Clinical Research, Inc.
Cleveland, Ohio, United States
TLM Medical Services, LLC
Columbia, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Washington Center for Weight Management and Research, Inc.
Arlington, Virginia, United States
Allegiance Research Specialists
Wauwatosa, Wisconsin, United States
Start Date
March 8, 2021
Primary Completion Date
September 15, 2022
Completion Date
October 7, 2022
Last Updated
November 2, 2023
387
ACTUAL participants
BI 456906
DRUG
Placebo
DRUG
Lead Sponsor
Boehringer Ingelheim
NCT01143454
NCT07472881
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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