Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06982131

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Plc (LPRA) - Netherlands

Groningen, 9728 NZ, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7795081

Drug

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

Other names: CT-996, RG6652

Placebo

Drug

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

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.

Other names: Crestor®

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.

Other names: Livazo®, Livalo®, Zypitamag®

Primary outcomes

  1. Incidence and Severity of Adverse Events

    Time frame: From the first dose of study treatment until the final visit (up to 111 days)

  2. Incidence of Abnormal Clinical Laboratory Test Results

    Time frame: From the first dose of study treatment until the final visit (up to 111 days)

  3. Incidence of Abnormal Vital Sign Assessments

    Time frame: From the first dose of study treatment until the final visit (up to 111 days)

  4. Incidence of Abnormal Electrocardiogram Parameters

    Time frame: From the first dose of study treatment until the final visit (up to 111 days)

  5. Maximum Plasma Concentration Observed (Cmax) of Rosuvastatin, Administered Alone and in Combination with RO7795081

    Time frame: Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5

  6. Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin, Administered Alone and in Combination with RO7795081

    Time frame: Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5

  7. 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

    Time frame: Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5

  8. AUC from Time 0 to Infinity (AUCinf) of Rosuvastatin, Administered Alone and in Combination with RO7795081

    Time frame: Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5

  9. Cmax of Pitavastatin, Administered Alone and in Combination with RO7795081

    Time frame: Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4

  10. Tmax of Pitavastatin, Administered Alone and in Combination with RO7795081

    Time frame: Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4

  11. AUClast of Pitavastatin, Administered Alone and in Combination with RO7795081

    Time frame: Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4

  12. AUCinf of Pitavastatin, Administered Alone and in Combination with RO7795081

    Time frame: Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4

Secondary outcomes

  1. Plasma Concentration of RO7795081 Over Time, Administered Alone and in Combination with Rosuvastatin and Pitavastatin

    Time frame: 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

  2. Cmax of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin

    Time frame: 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

  3. Tmax of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin

    Time frame: 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

  4. AUClast of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin

    Time frame: 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

  5. AUCinf of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin

    Time frame: 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 contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: BP45800 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. Only)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 21, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.