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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-11

Study Completion Date

2024-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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BI 1820237 treatment group

Group Type EXPERIMENTAL

BI 1820237

Intervention Type DRUG

BI 1820237

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the Investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the Investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy, bariatric surgery or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes