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.
2 other identifiers
interventional
131
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 obesity
Started Jul 2018
Typical duration for phase_1 obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2018
CompletedFirst Posted
Study publicly available on registry
July 19, 2018
CompletedStudy Start
First participant enrolled
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedMarch 22, 2021
March 1, 2021
1.7 years
July 4, 2018
March 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme
Up to 132 days
Secondary Outcomes (2)
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
Study Arms (2)
BI 456906
EXPERIMENTALPlacebo
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Profil Mainz GmbH & Co. KG
Mainz, 55116, Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460, Germany
Related Publications (1)
Jungnik A, Arrubla Martinez J, Plum-Morschel L, Kapitza C, Lamers D, Thamer C, Scholch C, Desch M, Hennige AM. Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon-like peptide-1 receptor agonist BI 456906. Diabetes Obes Metab. 2023 Apr;25(4):1011-1023. doi: 10.1111/dom.14948. Epub 2023 Jan 30.
PMID: 36527386DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2018
First Posted
July 19, 2018
Study Start
July 26, 2018
Primary Completion
April 20, 2020
Study Completion
April 30, 2020
Last Updated
March 22, 2021
Record last verified: 2021-03