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Can kidney health change how a new drug works?

NCT ID NCT07741604

Knowledge-focused Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study looks at how different levels of kidney function affect the way the body handles an experimental drug called RO7795081. Researchers will give a single oral dose to people with various degrees of kidney impairment and compare them to people with normal kidney function. The goal is to see if kidney problems change drug levels in the blood and whether the drug is safe. This information could help guide future dosing recommendations for people with kidney disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RO7795081 (also known as CT-996), an experimental drug given as a single oral dose
What this could lead to
If successful, this study could help determine the right dosing of RO7795081 for people with kidney problems, potentially making future treatments safer and more effective for them.
What could go wrong
This is an early-phase study with a small number of participants, so results may not apply to everyone. The drug may have side effects, and the study may not lead to a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

kidney failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal impairment

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GCP Research - Florida

    RECRUITING

    St. Petersburg, Florida, 33705, United States

  • Panax Clinical Research, LLC

    RECRUITING

    Miami Lakes, Florida, 33014, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.