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Clinical Trials in the USA / NCT07741604
Recruiting Phase 1

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

NCT07741604 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 1
Started
2026-09-09
Last updated
2026-10-09

Condition(s) studied

Renal Impairment

Investigational drug(s) / intervention(s)

RO7795081 →

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
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

Primary outcome measure(s)

  • 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

Trial sites (3)

FacilityCityRegionStatus
Panax Clinical Research, LLC Miami Lakes Florida Recruiting
Orlando Clinical Research Center Orlando Florida Recruiting
GCP Research - Florida St. Petersburg Florida Recruiting

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Other trials for the same condition

A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function Active, not recruiting
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A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07741604 on ClinicalTrials.gov ↗ ← All trials in the USA