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

Obesity Clinical Trial

Official title:

A Phase I, Blinded Within Dose Groups, Multiple Dose, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Different Titration Schemes of BI 456906 in Patients With Obesity and Overweight.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03591718
• Other study ID #: 1404-0003
• Secondary ID: 2018-000250-22
• Status: Completed
• Phase: Phase 1
• Start date: July 26, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: March 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: April 30, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• BI 456906
Solution for injection
• Placebo
solution for injection

Locations

Country	Name	City	State
Germany	Profil Mainz GmbH & Co. KG	Mainz
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme		Up to 132 days
Secondary	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
Secondary	Cmax (maximum measured concentration of the analyte in plasma) after first dose		Up to 132 days

External Links

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