Study S001742

A Double-blind, Randomized, Placebo-controlled, Multiple-dose, Parallel Group With Nested Crossover Design Trial With Moxifloxacin as Positive Control to Evaluate the Effects of Multiple Subcutaneous Doses of BI 456906 in a Titration Scheme on Cardiac Safety Parameters in (Otherwise) Healthy Male and Female Subjects With Overweight/Obesity

ClinicalTrials.gov record

Registration

Registration: NCT06200467
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 110
Start: 2024-03-13
Primary completion: 2025-10-22
Lead sponsor: Boehringer Ingelheim
Conditions: Overweight; Obesity
Interventions: COMBINATION_PRODUCT:BI 456906; COMBINATION_PRODUCT:Placebo to BI 456906; DRUG:Moxifloxacin; DRUG:Placebo to moxifloxacin
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: REGISTRY:2023-506375-10-00; OTHER:U1111-1295-4369; NIH:2023

Registered primary outcomes

Time-matched QTcI change from baseline (ΔQTcI) collected at the same time points as the BI 456906 plasma concentrations up to a maximum of 30 weeks after first drug administration of BI 456906 / BI 456906-placebo [up to 30 weeks.]

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