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NCT Number: NCT07741604

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

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.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7795081

Drug

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

Other names: CT-996

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of RO7795081

    Time frame: At prespecified timepoints from Day 1 to Day 14

  2. 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

  3. AUC From Time 0 to Infinity (AUCinf) of RO7795081

    Time frame: At prespecified timepoints from Day 1 to Day 14

Secondary outcomes

  1. Incidence and Severity of Adverse Events

    Time frame: Baseline up to Day 14

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

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

CONTACT

[email protected]

888-662-6728

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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