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Completed

NCT Number: NCT03591718

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

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Mainz GmbH & Co. KG, Mainz, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BI 456906

Drug

Solution for injection

Placebo

Drug

solution for injection

Primary outcomes

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 Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme

    Time frame: Up to 132 days

Secondary outcomes

  1. AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)

    Time frame: Up to 168 hours

  2. Cmax (maximum measured concentration of the analyte in plasma) after first dose

    Time frame: Up to 132 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 19, 2018
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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