GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 1

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 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

Lead sponsor

Hoffmann-La Roche

Asset

CT-996 / RO7795081

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI ≥27•Healthy volunteers

Primary endpoints

•Incidence and Severity of Adverse Events•Abnormal Clinical Laboratory Test Results•Abnormal Vital Sign Assessments

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06982131

Org study IDBP45800

Secondary ID2024-519277-18-00

Timeline

Milestones

Study first posted2025-05-21actual

Study start2025-06-04actual

Last update posted2026-05-05actual

Primary completion2026-12-04estimated

Study completion2026-12-04estimated

Assets

Investigational agents

CT-996 / RO7795081

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

17 endpoints

Primary/protocol endpoint

Incidence and Severity of Adverse Events

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

descriptive

Primary/protocol endpoint

Incidence of Abnormal Clinical Laboratory Test Results

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

event count, event

Primary/protocol endpoint

Incidence of Abnormal Vital Sign Assessments

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

event count, event

Primary/protocol endpoint

Incidence of Abnormal Electrocardiogram Parameters

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

event count, event

Primary/protocol endpoint

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

concentration, descriptive

Primary/protocol endpoint

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

time to event, event

Primary/protocol endpoint

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

concentration, descriptive

Primary/protocol endpoint

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

concentration, descriptive

Primary/protocol endpoint

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

concentration, descriptive

Primary/protocol endpoint

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

concentration, descriptive

Primary/protocol endpoint

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

descriptive

Primary/protocol endpoint

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

descriptive

Secondary/protocol endpoint

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

concentration, descriptive

Secondary/protocol endpoint

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

concentration, descriptive

Secondary/protocol endpoint

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

concentration, descriptive

Secondary/protocol endpoint

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

descriptive

Secondary/protocol endpoint

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

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.