A Study Investigating the Safety of RO7795081 and How the Body Processes RO7795081 in People With Normal or Decreased Kidney Functions
August 28, 2026 updated by: Hoffmann-La Roche
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
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Study Contact Backup
- Name: Reference Study ID Number: BP46039 https://forpatients.roche.com/ No attachments to email below.
- Phone Number: 888-662-6728
- Email: global-roche-genentech-trials@gene.com
Study Locations
-
-
Florida
-
Miami Lakes, Florida, United States, 33014
- Recruiting
- Panax Clinical Research, LLC
-
St. Petersburg, Florida, United States, 33705
- Recruiting
- GCP Research - Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1: Participants with Normal Renal Function, RO7795081
Participants with normal renal function will receive a single oral dose of RO7795081.
|
Participants will receive RO7795081 as per the schedule described in the protocol.
Other Names:
|
|
Experimental: Group 2: Participants with Severe Renal Impairment, RO7795081
Participants with severe renal impairment or kidney failure not receiving dialysis will receive a single oral dose of RO7795081.
|
Participants will receive RO7795081 as per the schedule described in the protocol.
Other Names:
|
|
Experimental: Group 3: Participants with Moderate Renal Impairment, RO7795081
Participants with moderate renal impairment will receive a single oral dose of RO7795081.
|
Participants will receive RO7795081 as per the schedule described in the protocol.
Other Names:
|
|
Experimental: Group 4: Participants with Mild Renal Impairment, RO7795081
Participants with mild renal impairment will receive a single oral dose of RO7795081.
|
Participants will receive RO7795081 as per the schedule described in the protocol.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maximum Plasma Concentration (Cmax) of RO7795081
Time Frame: At prespecified timepoints from Day 1 to Day 14
|
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
Time Frame: At prespecified timepoints from Day 1 to Day 14
|
At prespecified timepoints from Day 1 to Day 14
|
|
AUC From Time 0 to Infinity (AUCinf) of RO7795081
Time Frame: At prespecified timepoints from Day 1 to Day 14
|
At prespecified timepoints from Day 1 to Day 14
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence and Severity of Adverse Events
Time Frame: Baseline up to Day 14
|
Baseline up to Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 31, 2026
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Study Registration Dates
First Submitted
July 29, 2026
First Submitted That Met QC Criteria
July 29, 2026
First Posted (Actual)
August 3, 2026
Study Record Updates
Last Update Posted (Actual)
September 1, 2026
Last Update Submitted That Met QC Criteria
August 28, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP46039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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