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

NCT06982131 | Recruiting Phase 1

• 2 other identifiers: BP458002024-519277-18-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (12)

• 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

Secondary Outcomes (5)

• 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

• 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

Study Arms (2)

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

EXPERIMENTAL

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

Drug: RO7795081; Drug: Rosuvastatin; Drug: Pitavastatin

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

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Rosuvastatin; Drug: Pitavastatin

Interventions

RO7795081 DRUG

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

Also known as: CT-996, RG6652

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

Placebo DRUG

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

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

Rosuvastatin 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.

Also known as: Crestor®

Arm 1: ROS Alone, Then PIT Alone, Then RO7795081 Alone, Then RO7795081 + ROS, Then RO7795081 + PIT; Arm 2: ROS Alone, Then PIT Alone, Then Placebo Alone, Then Placebo + ROS, Then Placebo + PIT

Pitavastatin 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.

Also known as: Livazo®, Livalo®, Zypitamag®

Arm 1: ROS Alone, Then PIT Alone, Then RO7795081 Alone, Then RO7795081 + ROS, Then RO7795081 + PIT; Arm 2: ROS Alone, Then PIT Alone, Then Placebo Alone, Then Placebo + ROS, Then Placebo + PIT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

ICON Plc (LPRA) - Netherlands

Groningen, 9728 NZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Rosuvastatin Calcium; pitavastatin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: BP45800 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): December 4, 2026
• Study Completion (Estimated): December 4, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)