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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT03591718 (opens ClinicalTrials.gov in a new tab)Other id1404-0003Other id2018-000250-22Other id2018
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
131 participants (actual)
Sponsor
Boehringer Ingelheim · Industry
Design
Randomized · Double masking
Countries
1 country

Germany

Start
26 Jul 2018
Primary completion
20 Apr 2020
Completion
30 Apr 2020
First posted
19 Jul 2018
Last update posted
22 Mar 2021
Conditions
Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018201920202021
  1. Ph 1

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

    NCT03591718

    26 Jul 2018 to 30 Apr 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • BI 456906Drug
  • PlaceboDrug

Arms2

  • Experimental

    BI 456906

  • Experimental

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

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 Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme

    Time frame · Up to 132 days

Secondary outcomes(2)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2023

12 results

Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon-like peptide-1 receptor agonist BI 456906.

Jungnik et al. 2023Diabetes, obesity & metabolismcited by 55

PMID 36527386DOI 10.1111/dom.14948PUB-36527386

Full text at the publisher12 results
Publisher pageSee results (12)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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