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

Roche

Status and phase: Enrolling; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: Rosuvastatin; Drug: RO7795081; Drug: Placebo; Drug: Pitavastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06982131

BP45800

2024-519277-18-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: Pitavastatin

Drug: RO7795081

Drug: Rosuvastatin

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

Placebo Comparator group

Description:

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

Treatment:

Drug: Pitavastatin

Drug: Placebo

Drug: Rosuvastatin