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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT03591718
Collaborator
(none)
131
Enrollment
2
Locations
2
Arms
21.2
Actual Duration (Months)
65.5
Patients Per Site
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 456906
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
131 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jul 26, 2018
Actual Primary Completion Date :
Apr 20, 2020
Actual Study Completion Date :
Apr 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: BI 456906

Drug: BI 456906
Solution for injection
Experimental: Placebo

Drug: Placebo
solution for injection

Outcome Measures

Primary Outcome Measures

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 Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme [Up to 132 days]

Secondary Outcome Measures

  1. 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]

  2. Cmax (maximum measured concentration of the analyte in plasma) after first dose [Up to 132 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Profil Mainz GmbH & Co. KG Mainz Germany 55116
2 Profil Institut für Stoffwechselforschung GmbH Neuss Germany 41460

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03591718
Other Study ID Numbers:
  • 1404-0003
  • 2018-000250-22
First Posted:
Jul 19, 2018
Last Update Posted:
Mar 22, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Obesity

Study Results

No Results Posted as of Mar 22, 2021