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

Registration

Registration

NCT06982131

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

ACTIVE_NOT_RECRUITING

Enrollment

40

Start

2025-06-04

Primary completion

2026-12-07

Lead sponsor

Hoffmann-La Roche

Conditions

Overweight; Obesity

Interventions

DRUG:RO7795081; DRUG:Placebo; DRUG:Rosuvastatin; DRUG:Pitavastatin

Results posted

FALSE

Individual participant data sharing

NO

Secondary identifiers

CTIS:2024-519277-18-00

Registered primary outcomes

• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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]