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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-04

Study Completion Date

2026-06-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 2: ROS Alone, Then PIT Alone, Then Placebo Alone, Then Placebo + ROS, Then Placebo + PIT

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Rosuvastatin

Intervention Type DRUG

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

Pitavastatin

Intervention Type DRUG

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

Arm 1: ROS Alone, Then PIT Alone, Then RO7795081 Alone, Then RO7795081 + ROS, Then RO7795081 + PIT

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

Group Type EXPERIMENTAL

RO7795081

Intervention Type DRUG

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

Rosuvastatin

Intervention Type DRUG

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

Pitavastatin

Intervention Type DRUG

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

Interventions

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RO7795081

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Rosuvastatin

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

Intervention Type DRUG

Pitavastatin

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

Intervention Type DRUG

Other Intervention Names

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CT-996 RG6652 Crestor® Livazo® Livalo® Zypitamag®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes