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

Launched by HOFFMANN-LA ROCHE · May 13, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called RO7795081 to see if it is safe and how it affects the way the body processes two cholesterol-lowering medications, pitavastatin and rosuvastatin. The study will involve healthy adults who are overweight or obese. Participants will take RO7795081 in different sequences to understand its effects better. The goal is to ensure that this new treatment is safe for people who may need it in the future.

To be eligible for the study, participants need to be healthy adults aged between 18 and 65, with a body mass index (BMI) of 27 or higher, indicating they are overweight or obese. They should not have any significant health issues that could complicate the study, such as serious heart, liver, or kidney problems. Participants will need to agree to use contraception during the study and will undergo a series of health checks to ensure they are suitable for the trial. If you join this study, you can expect to take the medication and undergo regular health assessments to monitor your safety and how your body responds to the treatment. This trial is not yet recruiting, so keep an eye out for updates if you are interested in participating.

Gender

ALL

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 or within 34 days after the last study drug administration
• • 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