Actively Recruiting
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
Led by Hoffmann-La Roche · Updated on 2026-05-05
40
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 65 years
- Body Mass Index (BMI) of 27.0 kg/m² or higher at screening and Day -1 of Period 1
- Stable body weight with less than 5% gain or loss in the 2 months before screening and between screening and Day -1 of Period 1
- No clinically relevant findings on physical exams, medical history, vital signs, ECG, blood tests, or urinalysis
- No suspicion of cognitive impairment or dementia
- Not under judicial supervision, guardianship, or curatorship
- Agreement to follow contraception requirements
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Any medical condition found during screening or baseline that makes participation unsafe or prevents completing the study
- History or presence of significant cardiovascular, lung, liver, kidney, digestive, hormonal, blood, neurological, psychiatric, metabolic disorders, allergic diseases, infertility, cancer, or cirrhosis
- Any medical condition affecting drug absorption, metabolism, or elimination
- History of seizures (except benign childhood febrile seizures), epilepsy, serious brain trauma, or central nervous system infections
- History of acute or chronic metabolic acidosis, including diabetic ketoacidosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ICON Plc (LPRA) - Netherlands
Groningen, Netherlands, 9728 NZ
Actively Recruiting
Research Team
R
Reference Study ID Number: BP45800 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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