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Active, not recruitingNCT06982131Updated Sep 9, 2026

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

A Phase 1 interventional study of RO7795081 and Placebo in Overweight and Obesity, sponsored by Hoffmann-La Roche. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Overweight
  • Obesity
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's planned enrollment of 40 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    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

    Drug: RO7795081 · Drug: Rosuvastatin · Drug: Pitavastatin

  • Placebo comparator
    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

    Drug: Placebo · Drug: Rosuvastatin · Drug: Pitavastatin

Interventions

  • DrugRO7795081

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

    Also known as: CT-996, RG6652

  • DrugPlacebo

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

  • DrugRosuvastatin

    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®

  • DrugPitavastatin

    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®

06

What researchers measure

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

07

Study locations

1 site
  • ICON Plc (LPRA) - Netherlands
    Groningen, 9728 NZ, Netherlands
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06982131
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
May 21, 2025
Start date
Jun 4, 2025
Primary completion
Dec 7, 2026 (estimated)
Completion
Dec 7, 2026 (estimated)
Last update
Sep 9, 2026

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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