Recruiting
Phase 1

RO7795081

Sponsor:

Hoffmann-La Roche

Code:

NCT07741604

Conditions

Renal Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

RO7795081

Study Details

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

Study ID

NCT07741604

Start date

Sep 9, 2026

Status verified date

Oct, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: Participants with Normal Renal Function, RO7795081

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

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.

experimental: Group 3: Participants with Moderate Renal Impairment, RO7795081

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

experimental: Group 4: Participants with Mild Renal Impairment, RO7795081

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

Interventions

RO7795081

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

Primary outcome measure

  • Maximum Plasma Concentration (Cmax) of RO7795081 [ Time Frame: 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 ]
  • AUC From Time 0 to Infinity (AUCinf) of RO7795081 [ Time Frame: At prespecified timepoints from Day 1 to Day 14 ]

Central Contacts and Locations

Central contacts

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

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

Locations

Panax Clinical Research, LLC

Recruiting

Miami Lakes, Florida, United States, 33014

Orlando Clinical Research Center

Recruiting

Orlando, Florida, United States, 32809

GCP Research - Florida

Recruiting

St. Petersburg, Florida, United States, 33714

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.