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Recruiting Phase 1 NCT06982131

A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants

Trial Parameters

Condition Overweight
Sponsor Hoffmann-La Roche
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-06-04
Completion 2026-12-04
All Conditions
Interventions
RO7795081PlaceboRosuvastatin

Brief Summary

This is a randomized, investigator-and-participant-blind, placebo-controlled, fixed sequence, cross-over, Phase 1 study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of orally administered RO7795081 and the effect of a steady-state dose of orally administered RO7795081 on the pharmacokinetics of pitavastatin and rosuvastatin in otherwise healthy, overweight or obese adult participants.

Eligibility Criteria

Inclusion Criteria: * Healthy participants with no clinically relevant findings on physical examination at screening and at baseline (including detailed medical and surgical history, vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis); with no suspicion of cognitive impairment or dementia as judged by the Investigator; who are not under judicial supervision, guardianship, or curatorship. * Body Mass Index (BMI) ≥27.0 kg/m\^2 at screening and on Day -1 of Period 1 * Stable body weight (defined as \<5% gain or loss) in the 2 months prior to screening as per verbal report by the participant and for the period between screening and Day -1 of Period 1 as per measured weight * Agreement to adhere to the contraception requirements Exclusion Criteria: * Pregnant, breastfeeding, or intending to become pregnant during the study * Any condition or disease detected during the medical interview or physical examination that would render the participant unsuitable for the study, pl

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