A Study to Test Different Doses of BI 456906 in Patients With Obesity

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

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-26

Study Completion Date

2020-04-30

Brief Summary

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Main objective is to investigate the tolerability of different titration schemes of BI 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BI 456906

Group Type EXPERIMENTAL

BI 456906

Intervention Type DRUG

Solution for injection

Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

solution for injection

Interventions

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BI 456906

Solution for injection

Intervention Type DRUG

Placebo

solution for injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female patients ≥ 18 years and \< 70 years of age at screening
* Body Mass Index (BMI) ≥ 27 kg/m2 and \<40 kg/m2 at screening
* A minimum absolute body weight of 70 kg at screening and a stable body weight (defined as no more than 5% change) 3 months prior to screening
* HbA1c \<6.5%

Exclusion Criteria

* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Supine blood pressure (BP) ≥160/100 mmHg at screening
* Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No