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

Part of paid clinical trials in Walnut Creek, California.

Sponsor
Boehringer Ingelheim
Study ID
NCT04667377
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BI 456906 — DRUG
    BI 456906
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
Mar 8, 2021
Status verified
Oct 2023
Primary completion
Sep 15, 2022
Completion
Oct 7, 2022

Study Design

Enrollment
387 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 0.6 mg BI 456906
  • Placebo Comparator: Placebo group
  • Experimental: 2.4 mg BI456906
  • Experimental: 3.6 mg BI 456906
  • Experimental: 4.8 mg BI 456906

Primary Outcome Measure

Percentage Change in Body Weight From Baseline to Week 46 [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46. ]

Locations (10)

FacilityCityStateZIPSite coordinators
Diablo Clinical ResearchWalnut CreekCalifornia94598-
L-MARC Research CenterLouisvilleKentucky40213-
Lucas Research, Inc.Morehead CityNorth Carolina28557-
PMG Research of Wilmington, LLCWilmingtonNorth Carolina28401-
Valley Weight Loss ClinicFargoNorth Dakota58104-
Velocity Clinical Research, Inc.ClevelandOhio44122-
TLM Medical Services, LLCColumbiaSouth Carolina29204-
Coastal Carolina Research CenterNorth CharlestonSouth Carolina29405-
Washington Center for Weight Management and Research, Inc.ArlingtonVirginia22206-
Allegiance Research SpecialistsWauwatosaWisconsin53226-

Find similar trials in Walnut Creek, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Diablo Clinical Research· Walnut Creek, CAL-MARC Research Center· Louisville, KYLucas Research, Inc.· Morehead City, NCPMG Research of Wilmington, LLC· Wilmington, NCValley Weight Loss Clinic· Fargo, NDVelocity Clinical Research, Inc.· Cleveland, OH

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