Renal ImpairmentPhase 1NCT07741604
A Study Investigating the Safety of RO7795081 and How the Body Processes RO7795081 in People With Normal or Decreased Kidney Functions
A Phase 1 study testing RO7795081 in people with Renal Impairment, run by Hoffmann-La Roche at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- RO7795081
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Sep 2026to 1 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: BP46039 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
United States3 sites, 3 recruiting
- Recruiting
Panax Clinical Research, LLC
Miami Lakes, Florida, 33014
- Recruiting
Orlando Clinical Research Center
Orlando, Florida, 32809
- Recruiting
GCP Research - Florida
St. Petersburg, Florida, 33714
About this study
Official 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
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
- Being tested
- RO7795081
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7795081Drug
Also called CT-996
Participants will receive RO7795081 as per the schedule described in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Participants with Normal Renal Function, RO7795081 | Experimental | Participants with normal renal function will receive a single oral dose of RO7795081. Receives: Drug: RO7795081 |
| Group 2: Participants with Severe Renal Impairment, RO7795081 | Experimental | Participants with severe renal impairment or kidney failure not receiving dialysis will receive a single oral dose of RO7795081. Receives: Drug: RO7795081 |
| Group 3: Participants with Moderate Renal Impairment, RO7795081 | Experimental | Participants with moderate renal impairment will receive a single oral dose of RO7795081. Receives: Drug: RO7795081 |
| Group 4: Participants with Mild Renal Impairment, RO7795081 | Experimental | Participants with mild renal impairment will receive a single oral dose of RO7795081. Receives: Drug: RO7795081 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of RO7795081
Measured: 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
Measured: At prespecified timepoints from Day 1 to Day 14
AUC From Time 0 to Infinity (AUCinf) of RO7795081
Measured: At prespecified timepoints from Day 1 to Day 14
Secondary outcomes (1)
Incidence and Severity of Adverse Events
Measured: Baseline up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start9 Sep 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741604
- Sponsor's protocol ID
- BP46039
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07741604
- Acronym / sponsor ID
- BP46039
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Participants with Normal Renal Function, RO7795081 | Experimental | Drug: RO7795081Participants with normal renal function will receive a single oral dose of RO7795081. |
| Group 2: Participants with Severe Renal Impairment, RO7795081 | Experimental | Drug: RO7795081Participants with severe renal impairment or kidney failure not receiving dialysis will receive a single oral dose of RO7795081. |
| Group 3: Participants with Moderate Renal Impairment, RO7795081 | Experimental | Drug: RO7795081Participants with moderate renal impairment will receive a single oral dose of RO7795081. |
| Group 4: Participants with Mild Renal Impairment, RO7795081 | Experimental | Drug: RO7795081Participants with mild renal impairment will receive a single oral dose of RO7795081. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7795081Also: CT-996Participants will receive RO7795081 as per the schedule described in the protocol. | Drug | Group 1: Participants with Normal Renal Function, RO7795081, Group 2: Participants with Severe Renal Impairment, RO7795081, Group 3: Participants with Moderate Renal Impairment, RO7795081, Group 4: Participants with Mild Renal Impairment, RO7795081 |
Primary outcome
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
1 secondary outcome
Incidence and Severity of Adverse Events
Time frame: Baseline up to Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: BP46039 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7795081 in people with Renal Impairment, run by Hoffmann-La Roche at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: BP46039 https://forpatients.roche.com/ No attachments to email below. (888-662-6728, global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of RO7795081 (time frame: At prespecified timepoints from Day 1 to Day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.