A Study in People With Overweight or Obesity to Test How Well Different Doses of BI 1820237 Are Tolerated When Given Alone or in Combination With Either Semaglutide or BI 456906

Sponsor
Boehringer Ingelheim
Study ID
NCT05751226
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • BI 1820237 — DRUG
    BI 1820237
  • semaglutide — DRUG
    semaglutide
  • Placebo — DRUG
    Placebo
  • BI 456906 — DRUG
    BI 456906

Study Details

This study is open to adults between 18 and 55 years of age who are living with overweight or obesity. People with a body mass index (BMI) from 27 to 40 kg/m2 can join the study. The main purpose of this study is to find out how a medicine called BI 1820237 is tolerated by people with overweight or obesity when taken alone or in combination with a medicine called semaglutide or with a medicine called BI 456906. Participants are divided into different groups. All participants in the study either take different doses of BI 1820237 or placebo. Some of the groups take either semaglutide or BI 456906 in addition. Each participant has an equal chance of being in each group. All participants receive the study medicines as injections under the skin once a week for almost 5 months. Placebo injections look like BI 1820237 injections, but do not contain any medicine. Semaglutide is medicine that is already used for overweight or obesity. BI 456906 is another medicine that is being developed for the treatment of overweight and obesity. Participants are in the study for about 7 months. During this time, they visit the study site regularly. For some of the visits, the participants remain at the study site for 1 or 2 nights. At the study visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 1820237, semaglutide, or BI 456906.

Key Dates

Start date
Apr 11, 2023
Status verified
Jan 2025
Primary completion
Aug 1, 2024
Completion
Aug 1, 2024

Study Design

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

Arms

  • Experimental: BI 1820237 treatment group
  • Placebo Comparator: Placebo group
  • Experimental: BI 1820237 + semaglutide treatment group
  • Active Comparator: placebo + semaglutide group
  • Experimental: BI 1820237 + BI 456906 treatment group
  • Active Comparator: placebo + BI 456906 group

Primary Outcome Measure

Percentage of treatment-emergent adverse events [ Time Frame: Up to 180 days ]

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