Status:
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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, place the participant at undue risk, or interfere with the ability of the participant to complete the study in the opinion of the Investigator
- History or presence of any clinically significant cardiovascular, broncho-pulmonary, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, psychiatric, or metabolic disorders, allergic diseases, hypofertility, cancer, or cirrhosis
- History or evidence of any medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs
- History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g., meningitis)
- History of acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma
Key Trial Info
Start Date :
June 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 5 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06982131
Start Date
June 4 2025
End Date
June 5 2026
Last Update
January 9 2026
Active Locations (1)
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1
ICON Plc (LPRA) - Netherlands
Groningen, Netherlands, 9728 NZ