Safety testing of RO7795081 and its effects on pitavastatin and rosuvastatin levels in overweight adults

A Phase I, Randomized, Investigator/Participant-Blind, Placebo-Controlled, Fixed-Sequence Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Orally Administered RO7795081 and the Effect of Steady-State Dose of Orally Administered RO7795081 on the Pharmacokinetics of Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants

This trial will test whether RO7795081 is safe and how it changes blood levels of pitavastatin and rosuvastatin in otherwise healthy adults who are overweight or obese.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Hoffmann-La Roche (Industry-sponsored)
• Locations: 1 site (Groningen)
• Trial ID: NCT06982131 on ClinicalTrials.gov

What this trial studies

This randomized, investigator-and-participant-blind, placebo-controlled, fixed-sequence crossover Phase 1 trial gives multiple oral doses of RO7795081 to otherwise healthy adults with BMI ≥27 kg/m2 to characterize safety, tolerability, and pharmacokinetics. Participants receive RO7795081 and placebo in a crossover design, and will receive pitavastatin and rosuvastatin when RO7795081 is at steady state to test for drug-drug interactions. Serial blood sampling and routine safety assessments (labs, ECGs, vital signs, and adverse event monitoring) will be used to measure drug levels and safety signals. Results will define how RO7795081 is processed by the body and whether it alters levels of these two commonly used statins.

Who should consider this trial

Good fit: Otherwise healthy adults who are overweight or obese (BMI ≥27.0 kg/m2) with stable body weight and who meet standard screening criteria are eligible to participate.

Not a fit: People who are pregnant, breastfeeding, have significant medical conditions, or are otherwise unsuitable on medical screening are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, this could show RO7795081 is safe in overweight adults and whether it can be taken with pitavastatin or rosuvastatin without altering their blood levels, informing future dosing and safety guidance.

How similar studies have performed: Phase 1 crossover studies like this are commonly used and have reliably characterized safety and drug-drug interactions for other investigational drugs, but RO7795081 itself appears novel and untested in broader populations.

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, 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

Where this trial is running

Groningen

• ICON Plc (LPRA) - Netherlands — Groningen, Netherlands (Recruiting)

Study contacts

• Study coordinator: Reference Study ID Number: BP45800 https://forpatients.roche.com/

Conditions Overweight; Obesity