A Study Investigating the Safety of RO7795081 and How the Body Processes RO7795081 in People With Normal or Decreased Kidney Functions | NCT07741604

NCT07741604

Overview

NCT ID: NCT07741604
Lead Sponsor: Hoffmann-La RocheINDUSTRY
Official Title: 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
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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Aug 3, 2026Estimated
Primary Completion Date: Feb 1, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Phase 1
Enrollment: 60Estimated
Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Reference Study ID Number: BP46039 https://forpatients.roche.com/ No attachments to email below.Contact
global-roche-genentech-trials@gene.com

Similar Studies

Participant Group/Arms

Group 1: Participants with Normal Renal Function, RO7795081Experimental

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

Drug: RO7795081

Group 2: Participants with Severe Renal Impairment, RO7795081Experimental

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, RO7795081Experimental

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

Drug: RO7795081

Group 4: Participants with Mild Renal Impairment, RO7795081Experimental

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

Drug: RO7795081