A Study in People With Overweight or Obesity to Test How BI 1820237, BI 456906, or a Combination of Both Affects Brain Activity

Sponsor
Boehringer Ingelheim
Study ID
NCT06352424
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • BI 456906 — DRUG
    BI 456906
  • BI 1820237 — DRUG
    BI 1820237
  • Placebo for BI 1820237 — DRUG
    Placebo for BI 1820237
  • Placebo for BI 456906 — DRUG
    Placebo for BI 456906

Study Details

The main objective of this trial is to investigate the effect of BI 1820237 alone, BI 456906 alone, combination of BI 1820237 and BI 456906 versus placebo on brain activity.

Key Dates

Start date
Apr 30, 2024
Status verified
Mar 2025
Primary completion
Feb 24, 2025
Completion
Feb 24, 2025

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: A-B-C-D
    * A: Treatment Test 1 (T1): BI 1820237 + Placebo for BI 456906 * B: Treatment Test 2 (T2): BI 456906 + Placebo for BI 1820237 * C: Treatment Test 3 (T3): BI 1820237 + BI 456906 * D: Treatment Reference (R1, R2): Placebo for BI 1820237 + Placebo for BI 456906
  • Experimental: B-D-A-C
  • Experimental: C-A-D-B
  • Experimental: D-C-B-A

Primary Outcome Measure

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 [ Time Frame: 32 days plus up to 8 weeks wash-out for each sequence, up to 51 weeks ]

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