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

NCT07741604 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: BP46039
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) and safety of RO7795081, following a single oral dose in participants with renal impairment compared with participants with normal renal function. In Part 1, participants with normal renal function and participants with severe renal impairment or kidney failure not receiving dialysis will receive RO7795081. Part 2 is optional and will be conducted based on the results of Part 1. If Part 2 is implemented, additional participants with normal renal function and participants with mild or moderate renal impairment may be enrolled to receive RO7795081.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax) of RO7795081

  At prespecified timepoints from Day 1 to Day 14

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

  At prespecified timepoints from Day 1 to Day 14

• AUC From Time 0 to Infinity (AUCinf) of RO7795081

  At prespecified timepoints from Day 1 to Day 14

Secondary Outcomes (1)

• Incidence and Severity of Adverse Events

  Baseline up to Day 14

Study Arms (4)

Group 1: Participants with Normal Renal Function, RO7795081

EXPERIMENTAL

Participants with normal renal function will receive a single oral dose of RO7795081.

Drug: RO7795081

Group 2: Participants with Severe Renal Impairment, RO7795081

EXPERIMENTAL

Participants with severe renal impairment or kidney failure not receiving dialysis will receive a single oral dose of RO7795081.

Drug: RO7795081

Group 3: Participants with Moderate Renal Impairment, RO7795081

EXPERIMENTAL

Participants with moderate renal impairment will receive a single oral dose of RO7795081.

Drug: RO7795081

Group 4: Participants with Mild Renal Impairment, RO7795081

EXPERIMENTAL

Participants with mild renal impairment will receive a single oral dose of RO7795081.

Drug: RO7795081

Interventions

RO7795081 DRUG

Participants will receive RO7795081 as per the schedule described in the protocol.

Also known as: CT-996

Group 1: Participants with Normal Renal Function, RO7795081; Group 2: Participants with Severe Renal Impairment, RO7795081; Group 3: Participants with Moderate Renal Impairment, RO7795081; Group 4: Participants with Mild Renal Impairment, RO7795081

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Related Links

• Please use this form to submit your questions for a faster response: https://www.gene. com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing orcompleting the form. A nurse will respond within 24 business hours.

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: BP46039 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728; global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/ contact-us/submit-medical- inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share