RecruitingPhase 1

A Study Investigating the Safety of RO7795081 and How the Body Processes RO7795081 in People With Normal or Decreased Kidney Functions

A Two-part, Non-randomized, Open-label, Parallel-group Study to Assess the Effect of Renal Impairment on the Pharmacokinetics and Safety of RO7795081 Following a Single Oral Dose of RO7795081

Lead sponsor

Hoffmann-La Roche

Asset

CT-996 / RO7795081

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Renal impairment

Eligibility highlights

Primary endpoints

•Cmax of RO7795081•AUC From Time 0 to the Last Measurable Concentration (AUClast) of RO7795081•AUC From Time 0 to Infinity (AUCinf) of RO7795081

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07741604

Org study IDBP46039

Timeline

Milestones

Study first posted2026-08-03actual

Study start2026-09-09actual

Last update posted2026-10-09actual

Primary completion2028-02-01estimated

Study completion2028-02-01estimated

Assets

Investigational agents

CT-996 / RO7795081

Who this study enrolls

Renal impairment

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Ability and willingness to comply with all aspects of the protocol including completion of assessments for the duration of the study

•Estimated Glomerular Filtration Rate (eGFR) calculated using the Body Surface Area (BSA)-adjusted Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

•Participants with mild, moderate, or severe renal impairment/kidney failure and stable renal function

•Participants with normal renal function matched to participants with renal impairment

Exclusion criteria

•Any condition or disease detected during the medical interview/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 evidence of any medical condition other than renal impairment capable of significantly altering the absorption, metabolism, or elimination of drugs

•Surgical history of the gastrointestinal (GI) tract affecting gastric motility or altering the GI tract (with the exception of uncomplicated appendectomy and cholecystectomy)

•History of malignancy in the past 5 years, except for fully treated local basal carcinoma, or fully treated carcinoma in situ of cervix

•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

•History of cardiovascular, neurologic, psychiatric, or infectious disease

•History of hypersensitivity to any of the excipients in Glucagon-like Peptide-1 (GLP-1) agonists

•Bipolar disorder, schizophrenia, or any other serious psychiatric condition

•Type 1 diabetes or poorly controlled Type 2 diabetes

•Current or recent participation in another clinical study

•Pregnancy or breastfeeding

•Positive Human Immunodeficiency Virus (HIV), hepatitis B, hepatitis C, or tuberculosis test

•History of alcohol or substance abuse

Endpoints (4)

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

4 endpoints

Primary/protocol endpoint

Maximum Plasma Concentration (Cmax) of RO7795081

Time frame:At prespecified timepoints from Day 1 to Day 14

concentration, descriptive

Primary/protocol endpoint

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

Time frame:At prespecified timepoints from Day 1 to Day 14

concentration, descriptive

Primary/protocol endpoint

AUC From Time 0 to Infinity (AUCinf) of RO7795081

Time frame:At prespecified timepoints from Day 1 to Day 14

concentration, descriptive

Secondary/protocol endpoint

Incidence and Severity of Adverse Events

Time frame:Baseline up to Day 14

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.