GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 1

A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight

An Investigator- and Participant-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight

Lead sponsor

Hoffmann-La Roche

Asset

CT-996 / RO7795081

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight

Key I/E criteria

•BMI ≥24•Healthy volunteers

Primary endpoints

•Incidence, Severity, and Causal Relationship to Treatment of Adverse Events•Abnormal Clinical Laboratory Test Findings•Abnormal Vital Signs

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 IDNCT07499050

Org study IDYP46260

Timeline

Milestones

Study first posted2026-03-30actual

Study start2026-03-30actual

Last update posted2026-05-07actual

Primary completion2026-12-29estimated

Study completion2026-12-29estimated

Assets

Investigational agents

CT-996 / RO7795081

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring

•Participants who are ethnically Chinese and living in mainland China

•Body mass index (BMI) ≥24 kg/m^2 at screening

•Agreement to adhere to the contraception requirements

Exclusion criteria

•Any medical condition or disease that could be expected to progress, recur, or change to such an extent that it could bias the assessment of the clinical or mental status of the participant to a significant degree or put the participant at special risk in the opinion of the Investigator. Such conditions may include clinically significantly impaired endocrine, thyroid, hepatic, respiratory, or renal function for any reason, unstable diabetes mellitus and insulin dependent diabetes mellitus, clinically significant cardiovascular disease, pheochromocytoma, or history of any psychotic mental illness.

Endpoints (9)

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.

Coverage by outcome category

Safety / tolerability / PK

Other clinical outcomes

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

Incidence, Severity, and Causal Relationship to Treatment of Adverse Events

Time frame:Baseline to Safety Follow-Up (26 weeks)

descriptive

Primary/protocol endpoint

Incidence of Abnormal Clinical Laboratory Test Findings

Time frame:Baseline to Safety Follow-Up (26 weeks)

event count, event

Primary/protocol endpoint

Incidence of Abnormal Vital Signs

Time frame:Baseline to Safety Follow-Up (26 weeks)

event count, event

Primary/protocol endpoint

Incidence of Abnormal Electrocardiogram (ECG) Results

Time frame:Baseline to Safety Follow-Up (26 weeks)

event count, event

Secondary/protocol endpoint

Plasma Concentration of RO7795081

Time frame:At prespecified timepoints on Weeks 8, 14, 17, 19, 21, and 22

concentration, descriptive

Secondary/protocol endpoint

Maximum Plasma Concentration Observed (Cmax) of RO7795081

Time frame:At prespecified timepoints on Weeks 8, 14, and 22

concentration, descriptive

Secondary/protocol endpoint

Time to Cmax (Tmax) of RO7795081

Time frame:At prespecified timepoints on Weeks 8, 14, and 22

time to event, event

Secondary/protocol endpoint

Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of RO7795081

Time frame:At prespecified timepoints on Weeks 8, 14, and 22

concentration, descriptive

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

Incidence of Abnormal Psychiatry Parameters

Time frame:Baseline to Safety Follow-Up (26 weeks)

event count, event

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.