Study S000916

A Single-dose, Randomized, Placebo-controlled Phase I Study on the Effects of a Subcutaneous Dose of BI 1820237 and BI 456906, and Combination Thereof on Functional MRI Measurements in Otherwise Healthy Male and Female Individuals With Obesity/Overweight (Single-blind, Cross-over Design)

ClinicalTrials.gov record

Registration

Registration: NCT06352424
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: SINGLE
Status: COMPLETED
Enrollment: 23
Start: 2024-04-30
Primary completion: 2025-02-24
Lead sponsor: Boehringer Ingelheim
Conditions: Obesity
Interventions: DRUG:BI 456906; DRUG:BI 1820237; DRUG:Placebo for BI 1820237; DRUG:Placebo for BI 456906
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: REGISTRY:2023-506233-30-01; REGISTRY:U1111-1293-4672; NIH:2023

Registered primary outcomes

Blood Oxygen Level Dependent (BOLD) signal changes following treatment with single dose of BI 1820237 alone, BI 456906 alone, and combination of BI 1820237 + BI 456906 versus placebo [32 days plus up to 8 weeks wash-out for each sequence, up to 51 weeks]

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