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

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.

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: BI 456906

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 55116
    • Profil Mainz GmbH & Co. KG
  • Neuss, Germany, 41460
    • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Placebo	Drug: Placebo; solution for injection
EXPERIMENTAL: BI 456906	Drug: BI 456906; Solution for injection

What is the study measuring?

Primary Outcome Measures

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Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme	Up to 132 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Cmax (maximum measured concentration of the analyte in plasma) after first dose	Up to 132 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 26, 2018
• Primary Completion (ACTUAL): April 20, 2020
• Study Completion (ACTUAL): April 30, 2020

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (ACTUAL): July 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 1404-0003; 2018-000250-22 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. Studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to: 1.find information in order to request access to clinical study data, for listed studies. 2.request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No