OverweightPhase 1NCT06982131

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 study testing RO7795081, Rosuvastatin and Pitavastatin in people with Overweight and Obesity, run by Hoffmann-La Roche at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Overweight, Obesity
What is being tested?: RO7795081, Rosuvastatin and Pitavastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteNetherlands
Study dates: 4 Jun 2025to 7 Dec 2026
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Netherlands1 site

ICON Plc (LPRA) - Netherlands
Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official 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

Conditions: Overweight, Obesity
Being tested: RO7795081, Placebo, Rosuvastatin, Pitavastatin
Medical subject headings: Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RO7795081Drug
Also called CT-996, RG6652
RO7795081 will be administered orally during Periods 3, 4, and 5, according to the protocol.
PlaceboDrug
Placebo will be administered orally during Periods 3, 4, and 5, according to the protocol.
RosuvastatinDrug
Also called Crestor®
A single 10 mg dose of rosuvastatin (ROS) will be taken on Day 1 of Period 1 and on Day 1 of Period 4.
PitavastatinDrug
Also called Livazo®, Livalo®, Zypitamag®
A single 1 mg dose of pitavastatin (PIT) will be taken on Day 1 of Period 2 and on Day 1 of Period 5.

Study groups in NCT06982131
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Placebo; Drug: Rosuvastatin; Drug: Pitavastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence and Severity of Adverse Events
Measured: From the first dose of study treatment until the final visit (up to 111 days)
Incidence of Abnormal Clinical Laboratory Test Results
Measured: From the first dose of study treatment until the final visit (up to 111 days)
Incidence of Abnormal Vital Sign Assessments
Measured: From the first dose of study treatment until the final visit (up to 111 days)
Incidence of Abnormal Electrocardiogram Parameters
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jun 20257 Dec 2026

First posted21 May 2025
Study start4 Jun 2025
Primary completion7 Dec 2026 (estimated)
Study completion7 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for OverweightStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06982131
Sponsor's protocol ID: BP45800
Other IDs: 2024-519277-18-00
Status last verified: Sep 2026
First submitted: 13 May 2025
Last updated: 9 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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