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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
Conditions: Overweight, Obesity
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 40
Sponsor: Hoffmann-La Roche
Location: ICON Plc (LPRA) - Netherlands Groningen
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 \
Source: ClinicalTrials.gov (NCT06982131). StuddyBuddy aggregates publicly available trial information.