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

Phase 1

Recruiting

• Conditions: Overweight; Obesity
• Interventions: Drug: RO7795081; Drug: Placebo; Drug: Rosuvastatin; Drug: Pitavastatin

• Registration Number: NCT06982131
• Lead Sponsor: Hoffmann-La Roche

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Study First Posted: 2025-05-21
• Study Start: 2025-06-04
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-11
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1: ROS Alone, Then PIT Alone, Then RO7795081 Alone, Then RO7795081 + ROS, Then RO7795081 + PIT	RO7795081	Period 1: Rosuvastatin (ROS) alone; Period 2: Pitavastatin (PIT) alone; Period 3: RO7795081 alone; Period 4: RO7795081 in combination with ROS; Period 5: RO7795081 in combination with PIT
Arm 1: ROS Alone, Then PIT Alone, Then RO7795081 Alone, Then RO7795081 + ROS, Then RO7795081 + PIT	Rosuvastatin	Period 1: Rosuvastatin (ROS) alone; Period 2: Pitavastatin (PIT) alone; Period 3: RO7795081 alone; Period 4: RO7795081 in combination with ROS; Period 5: RO7795081 in combination with PIT
Arm 1: ROS Alone, Then PIT Alone, Then RO7795081 Alone, Then RO7795081 + ROS, Then RO7795081 + PIT	Pitavastatin	Period 1: Rosuvastatin (ROS) alone; Period 2: Pitavastatin (PIT) alone; Period 3: RO7795081 alone; Period 4: RO7795081 in combination with ROS; Period 5: RO7795081 in combination with PIT
Arm 2: ROS Alone, Then PIT Alone, Then Placebo Alone, Then Placebo + ROS, Then Placebo + PIT	Placebo	Period 1: Rosuvastatin (ROS) alone; Period 2: Pitavastatin (PIT) alone; Period 3: Placebo alone; Period 4: Placebo in combination with ROS; Period 5: Placebo in combination with PIT
Arm 2: ROS Alone, Then PIT Alone, Then Placebo Alone, Then Placebo + ROS, Then Placebo + PIT	Rosuvastatin	Period 1: Rosuvastatin (ROS) alone; Period 2: Pitavastatin (PIT) alone; Period 3: Placebo alone; Period 4: Placebo in combination with ROS; Period 5: Placebo in combination with PIT
Arm 2: ROS Alone, Then PIT Alone, Then Placebo Alone, Then Placebo + ROS, Then Placebo + PIT	Pitavastatin	Period 1: Rosuvastatin (ROS) alone; Period 2: Pitavastatin (PIT) alone; Period 3: Placebo alone; Period 4: Placebo in combination with ROS; Period 5: Placebo in combination with PIT

Primary Outcome Measures

Name	Time	Method
Incidence and Severity of Adverse Events	From the first dose of study treatment until the final visit (up to 111 days)
Incidence of Abnormal Clinical Laboratory Test Results	From the first dose of study treatment until the final visit (up to 111 days)
Incidence of Abnormal Vital Sign Assessments	From the first dose of study treatment until the final visit (up to 111 days)
Incidence of Abnormal Electrocardiogram Parameters	From the first dose of study treatment until the final visit (up to 111 days)
Maximum Plasma Concentration Observed (Cmax) of Rosuvastatin, Administered Alone and in Combination with RO7795081	Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5
Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin, Administered Alone and in Combination with RO7795081	Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5
Tmax of Pitavastatin, Administered Alone and in Combination with RO7795081	Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4
Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to the Last Measurable Concentration (AUClast) of Rosuvastatin, Administered Alone and in Combination with RO7795081	Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5
Cmax of Pitavastatin, Administered Alone and in Combination with RO7795081	Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4
AUClast of Pitavastatin, Administered Alone and in Combination with RO7795081	Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4
AUC from Time 0 to Infinity (AUCinf) of Rosuvastatin, Administered Alone and in Combination with RO7795081	Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5
AUCinf of Pitavastatin, Administered Alone and in Combination with RO7795081	Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4

Secondary Outcome Measures

Name	Time	Method
AUClast of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin	Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9
AUCinf of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin	Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9
Plasma Concentration of RO7795081 Over Time, Administered Alone and in Combination with Rosuvastatin and Pitavastatin	Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9
Cmax of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin	Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9
Tmax of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin	Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9

Trial Locations

Locations (1)

ICON Plc (LPRA) - Netherlands; 🇳🇱 Groningen, Netherlands