Obesity / Overweight / Pitavastatin · Phase 1 Trial

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

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 registry record describing a planned randomized, blinded, placebo-controlled crossover study of RO7795081 safety and its effect on the pharmacokinetics of two statins in healthy overweight or obese adults. No results are yet reported in this registry entry, so no efficacy or safety conclusions can be drawn.

What was studied

Phase 1, Interventional, Randomized, Crossover, Double masking, Basic Science purpose. Overweight, Obesity; age from 18 Years; to 65 Years; accepts healthy volunteers. Intervention: Arm 1: ROS Alone, Then PIT Alone, Then RO7795081 Alone, The…. Compared with: Arm 2: ROS Alone, Then PIT Alone, Then Placebo Alone, Then… — Placebo Comparator. n = 40. 1 site: Netherlands.

Key findings

Safety

Pharmacokinetic endpoints are surrogates; clinical safety and efficacy remain to be determined.

Who this may help

This is a preclinical-stage drug development record. Readers should await posted results before interpreting any safety or interaction signal. The study design is appropriate for early-phase assessment, but conclusions require completion and publication.

Plain-language summary

This is a Phase 1 clinical trial registry record with no results posted; it describes a planned safety and drug-drug interaction study in a small healthy population.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Incidence and Severity of Adverse Events (assessed at From the first dose of study treatment until the final visit (up to 111 days)); Incidence of Abnormal Clinical Laboratory Test Results (assessed at From the first dose of study treatment until the final visit (up to 111 days)); Incidence of Abnormal Vital Sign Assessments (assessed at From the first dose of study treatment until the final visit (up to 111 days)); Incidence of Abnormal Electrocardiogram Parameters (assessed at From the first dose of study treatment until the final visit (up to 111 days)); Maximum P…

DesignPhase 1, Interventional, Randomized, Crossover, Double masking, Basic Science purpose

PopulationOverweight, Obesity; age from 18 Years; to 65 Years; accepts healthy volunteers

Sample size40

InterventionArm 1: ROS Alone, Then PIT Alone, Then RO7795081 Alone, The…

ComparatorArm 2: ROS Alone, Then PIT Alone, Then Placebo Alone, Then… — Placebo Comparator

Setting1 site: Netherlands

Reported figures

Quoted from the source exactly as published.

Planned enrollment40

PhasePhase 1

Study durationup to 111 days

Primary outcome: Safety measuresIncidence and severity of adverse events, abnormal labs, vital signs, ECG parameters

Primary outcome: PharmacokineticsCmax, Tmax, AUClast, AUCinf of rosuvastatin (Periods 1 and 4) and pitavastatin (Periods 2 and 5)

Clinical bottom line

Caveats

This is a registry record only; no results are reported or available in this source.
Study is Phase 1 in healthy volunteers; findings will not directly inform clinical use in patients.
Pharmacokinetic endpoints are surrogates; clinical safety and efficacy remain to be determined.
Recruitment status is active but not recruiting; results timeline is not stated.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Randomized, blinded, placebo-controlled, crossover Phase 1 design.

Directness

limited

Healthy volunteers; pharmacokinetic surrogates, not clinical outcomes.

Consistency

insufficient

Registry record only; no results reported for comparison.

Risk of bias

moderate

Blinded design reduces bias; small Phase 1 sample and healthy population limit generalizability.

Sample adequacy

limited

Estimated 40 participants; typical for early-phase pharmacokinetic studies.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06982131). This is a study registration, not published results. Lead sponsor: Hoffmann-La Roche. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Overweight, Obesity. Interventions: DRUG: RO7795081; DRUG: Placebo; DRUG: Rosuvastatin; DRUG: Pitavastatin. Primary outcome measures: 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. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

ObesityOverweightPitavastatinNCT06982131RosuvastatinHoffmann-La RocheRO7795081