RecruitingPhase 1NCT06982131

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

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


Sponsor

Hoffmann-La Roche

Enrollment

40 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called RO7795081 in healthy adults who are overweight or obese. Researchers want to understand how the body processes this drug and whether it affects how the body handles two common cholesterol-lowering medications (pitavastatin and rosuvastatin). This is an early-stage safety study. **You may be eligible if...** - You are a healthy adult (no major diagnosed illnesses) - You have a BMI of 27.0 or above (overweight or obese) - Your body weight has been stable in the 2 months before the study - You are willing to use contraception during the study period **You may NOT be eligible if...** - You are pregnant, breastfeeding, or planning to become pregnant - You have any significant heart, kidney, liver, or other systemic illness - Your doctor determines you are not suitable based on physical examination or lab results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRO7795081

RO7795081 will be administered orally during Periods 3, 4, and 5, according to the protocol.

DRUGPlacebo

Placebo will be administered orally during Periods 3, 4, and 5, according to the protocol.

DRUGRosuvastatin

A single 10 mg dose of rosuvastatin (ROS) will be taken on Day 1 of Period 1 and on Day 1 of Period 4.

DRUGPitavastatin

A single 1 mg dose of pitavastatin (PIT) will be taken on Day 1 of Period 2 and on Day 1 of Period 5.


Locations(1)

ICON Plc (LPRA) - Netherlands

Groningen, Netherlands

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NCT06982131


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