NCT07741604 A Study Investigating the Safety of RO7795081 and How the Body Processes RO7795081 in People With Normal or Decreased Kidney Functions
| NCT ID | NCT07741604 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hoffmann-La Roche |
| Condition | Renal Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-09-09 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2026-09-09 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Reference Study ID Number: BP46039 https://forpatients.roche.com/ No attachments to email below.
✉ global-roche-genentech-trials@gene.com📞 888-662-6728
Clinical Trials
STUDY DIRECTOR
Hoffmann-La Roche
Frequently Asked Questions
Who can join the NCT07741604 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Renal Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07741604 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07741604 currently recruiting?
Yes, NCT07741604 is actively recruiting participants. Contact the research team at global-roche-genentech-trials@gene.com for enrollment information.
Where is the NCT07741604 trial being conducted?
This trial is being conducted at Miami Lakes, United States, Orlando, United States, St. Petersburg, United States.
Who is sponsoring the NCT07741604 clinical trial?
NCT07741604 is sponsored by Hoffmann-La Roche. The principal investigator is Clinical Trials at Hoffmann-La Roche. The trial plans to enroll 60 participants.