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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: BI 456906; Drug: Placebo

• Registration Number: NCT03591718
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-19
• Study Start: 2018-07-26
• Primary Completion: 2020-04-20
• Study Completion: 2020-04-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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%
• Further inclusion criteria apply

Read More

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
• Further exclusion criteria apply

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 456906	BI 456906	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme	Up to 132 days

Secondary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration of the analyte in plasma) after first dose	Up to 132 days
AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)	Up to 168 hours

Trial Locations

Locations (2)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany

Profil Mainz GmbH & Co. KG; 🇩🇪 Mainz, Germany