DRUG
BI 456906
Solution for injection
Status
Completed
Phase
Phase 1
Enrollment
131
Locations
2
Results
Not posted
Publications
1
Study 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.
Interventions
DRUG
Solution for injection
DRUG
solution for injection
Timeline
First posted
Jul 19, 2018
Study start
Jul 26, 2018
Primary completion
Apr 20, 2020
Study completion
Apr 30, 2020
Results posted
Not reported
Registry updated
Mar 22, 2021
Outcomes
Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme
Time frame · Up to 132 days
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
Cmax (maximum measured concentration of the analyte in plasma) after first dose
Time frame · Up to 132 days
Eligibility
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 locations
Germany. Showing up to 24 locations stored in the fast local snapshot.
Profil Mainz GmbH & Co. KG
Mainz, Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
Related trials
Boehringer Ingelheim · Healthy · Obesity
Phase 1
Recruiting
80
2026-07
Boehringer Ingelheim · Obesity
Phase 3
Completed
5,531
2026-07
Boehringer Ingelheim · Obesity
Phase 1
Active, not recruiting
29
2026-07
Boehringer Ingelheim · Metabolic Dysfunction Associated Steatohepatitis (MASH) · Liver Fibrosis
Phase 3
Recruiting
1,800
2026-07
Boehringer Ingelheim · Metabolic Dysfunction Associated Steatohepatitis
Phase 3
Recruiting
1,590
2026-07
Boehringer Ingelheim · Obesity · Diabetes Mellitus, Type 2
Phase 3
Completed
755
2026-06
Boehringer Ingelheim · Healthy · Obesity
Phase 1
Completed
56
2026-06
Boehringer Ingelheim · Obesity
Phase 1
Active, not recruiting
64
2026-05
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.