Study S000327

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.

ClinicalTrials.gov record

Registration

Registration: NCT03591718
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 131
Start: 2018-07-26
Primary completion: 2020-04-20
Lead sponsor: Boehringer Ingelheim
Conditions: Obesity
Interventions: DRUG:BI 456906; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: UNDECIDED
Secondary identifiers: EUDRACT_NUMBER:2018-000250-22; NIH:2018

Registered primary outcomes

Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme [Up to 132 days]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0049255	1665-P: Analysis of Glucose Biomarkers in Phase I and Phase II Studies of Survodutide in People with Type 2 Diabetes or Living with Overweight/Obesity Elif Ilhan Ekinci, Diabetes	2024	Other trial	DOI	cites ClinicalTrials.gov:NCT03591718
R0007419	Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon-like peptide-1 receptor agonist BI 456906. Jungnik A, Diabetes, obesity & metabolism	2023	Other trial	PMID 36527386 DOI	cites ClinicalTrials.gov:NCT03591718; registry reference DERIVED:36527386