GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081

An Open-Label, Fixed Sequence Study to Investigate the Effect of Multiple Oral Doses of Itraconazole, Multiple Oral Doses of Gemfibrozil, and Single Oral Dose of Cyclosporine, on the Pharmacokinetics of a Single Oral Dose of RO7795081 in Healthy Participants

Lead sponsor

Hoffmann-La Roche

Asset

CT-996 / RO7795081

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18-32•Healthy volunteers

Primary endpoints

•Part 1•Part 2

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06809608

Org study IDBP45670

Secondary ID2024-517360-37-00EU CT Number

Timeline

Milestones

Study first posted2025-02-05actual

Study start2025-02-13actual

Primary completion2025-06-16actual

Study completion2025-06-16actual

Last update posted2025-07-08actual

Assets

Investigational agents

CT-996 / RO7795081

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy biological males or females, defined by absence of evidence of any active or chronic disease

•Ability to communicate with the Investigator

•Able and willing to attend the necessary visits to the study site

•Not under judicial supervision, guardianship, or curatorship

•Body mass index (BMI) of 18 to 32 kg/m^2 inclusive, and a body weight of ≥50 kilograms at screening

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 presence of any clinically significant cardiovascular, bronchopulmonary, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, psychiatric, genitourinary, metabolic disorders, allergic diseases, cancer, or cirrhosis

•History or evidence of any medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs

•Surgical history of the 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

•History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or central nervous system infections (e.g., meningitis)

•Any major illness (in the opinion of the Investigator) within 1 month before the screening examination or any febrile illness (in the opinion of the Investigator) within 1 week prior to screening and within 1 week prior to admission

•History of clinically significant hypersensitivity (e.g., drugs [including but not limited to lidocaine, caffeine, povidone-iodine], excipients) or clinically significant allergic reactions

•Have an abnormal blood pressure at the time of screening and on baseline, confirmed by the average of 3 blood pressure measurements, properly measured with well-maintained equipment: supine systolic blood pressure <90 millimetres of mercury (mmHg) or >140 mmHg or diastolic blood pressure <45 mmHg or >90 mmHg

•Confirmed (based on the average of ≥ 3 consecutive measurements) resting pulse rate greater than 100 or less than 40 beats per minute at the time of screening and on baseline

•History or presence during screening and baseline of clinically significant ECG abnormalities before study drug administration (e.g., PQ/PR interval >210 milliseconds (ms), QTcF >450 ms [>470 ms female participants], based on the average interval on triplicate ECGs) or cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death)

•Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel, and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility

•Any suspicion or history of alcohol abuse and/or suspicion of regular consumption of drug of abuse (including cannabis-containing products) and/or evidence of current or previous drug of abuse (including cannabis-containing products) dependency within 5 years before screening

•Participants who, in the Investigator's judgment, pose a suicidal or homicidal risk, or any participant with a history of suicidal or homicidal attempts

•Bipolar disorder, schizophrenia or any other serious psychiatric condition (e.g., Axis I Disorder, DSM-IV-TR)

•Uncontrolled behavioral symptoms incompatible with compliance or evaluability (e.g., severe agitation, lack of impulse control, violence, and severe dysphoria)

•Any other medical condition not previously mentioned that could be expected to progress, recur, or change to such an extent that it could bias the assessment of the clinical or mental status of the participant to a significant degree or put the participant at special risk

•Presence of any acute or chronic illness or history of chronic illness not otherwise mentioned elsewhere and sufficient to invalidate the participant's participation in the trial or make it unnecessarily hazardous. Such conditions may include clinically significantly impaired endocrine, thyroid, hepatic, respiratory or renal function for any reason, unstable diabetes mellitus and insulin-dependent diabetes mellitus, clinically significant cardiovascular disease, pheochromocytoma, or history of any psychotic mental illness

•Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 6 weeks prior to Period 1 Day 1

•Vaccination within 6 weeks prior to Period 1 Day 1, including influenza and/or SARS-CoV-2/COVID-19 vaccination

•Use of any prohibited medications and food before study start and during the study

•Participants likely to need concomitant medication during the study period, with some exceptions

•Participation in an investigational drug or device study within 90 days prior to dosing, as calculated from the day of follow-up from the previous study or within 30 days

•Participation in an investigational drug study involving any therapeutic monoclonal antibody, protein derived from a monoclonal antibody, immunoglobulin therapy, or vaccine (with the exception of approved SARS-CoV-2/ COVID-19 vaccination) within 6 months prior to dosing (unless it can be documented that the participant was randomized to placebo) as calculated from the day of last dosing from the previous study

•Positive test for drugs of abuse or alcohol

•Positive result on human immunodeficiency virus (HIV)1 and HIV2, hepatitis C virus, or hepatitis B surface antigen

•Any suspicion or history of regular alcohol consumption for 1 month before screening defined as ≥21 drinks per week for males and ≥14 drinks per week for females

•Smokers who smoke more than 5 cigarettes per day or equivalent amount of tobacco (including e-cigarettes/vapes) as determined by history, and unable or unwilling not to smoke during the in-clinic period

•Donated over 450 mL of blood or blood products or had significant blood loss within 3 months prior to screening

•Dietary restrictions that would prohibit the consumption of standardized meals

•History of hypersensitivity to itraconazole (or any other triazole antifungal agent), gemfibrozil, cyclosporine, or their formulation ingredients

•Inability or unwillingness to meet study requirements

•Predictable poor compliance or inability to communicate well with the Investigator

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

14 endpoints

Primary/protocol endpoint

Part 1: Maximum Concentration Observed (Cmax) of RO7795081, Administered Alone and in Combination with Itraconazole

Time frame:Part 1, Period 1: Days 1 to 5 and 7; Part 1, Period 2: Days -4, -1, 1 to 10, 12, 14, 20, and 26

concentration, descriptive

Primary/protocol endpoint

Part 1: Time to Maximum Concentration Observed (Tmax) of RO7795081, Administered Alone and in Combination with Itraconazole

Time frame:Part 1, Period 1: Days 1 to 5 and 7; Part 1, Period 2: Days -4, -1, 1 to 10, 12, 14, 20, and 26

time to event, event

Primary/protocol endpoint

Part 1: Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of RO7795081, Administered Alone and in Combination with Itraconazole

Time frame:Part 1, Period 1: Days 1 to 5 and 7; Part 1, Period 2: Days -4, -1, 1 to 10, 12, 14, 20, and 26

concentration, descriptive

Primary/protocol endpoint

Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of RO7795081, Administered Alone and in Combination with Itraconazole

Time frame:Part 1, Period 1: Days 1 to 5 and 7; Part 1, Period 2: Days -4, -1, 1 to 10, 12, 14, 20, and 26

concentration, descriptive

Primary/protocol endpoint

Part 2: Cmax of RO7795081, Administered Alone and in Combination with Gemfibrozil or Cyclosporine

Time frame:Part 2, Period 1: Days 1 to 5 and 7; Part 2, Period 2: Days -3 to 5, and 7; Part 2, Period 3: Days -1 to 5, and 7; Part 2, Period 4: Days -1 to 5, 7, and 18

concentration, descriptive

Primary/protocol endpoint

Part 2: Tmax of RO7795081, Administered Alone and in Combination with Gemfibrozil or Cyclosporine

Time frame:Part 2, Period 1: Days 1 to 5 and 7; Part 2, Period 2: Days -3 to 5, and 7; Part 2, Period 3: Days -1 to 5, and 7; Part 2, Period 4: Days -1 to 5, 7, and 18

concentration, descriptive

Primary/protocol endpoint

Part 2: AUClast of RO7795081, Administered Alone and in Combination with Gemfibrozil or Cyclosporine

Time frame:Part 2, Period 1: Days 1 to 5 and 7; Part 2, Period 2: Days -3 to 5, and 7; Part 2, Period 3: Days -1 to 5, and 7; Part 2, Period 4: Days -1 to 5, 7, and 18

descriptive

Primary/protocol endpoint

Part 2: AUCinf of RO7795081, Administered Alone and in Combination with Gemfibrozil or Cyclosporine

Time frame:Part 2, Period 1: Days 1 to 5 and 7; Part 2, Period 2: Days -3 to 5, and 7; Part 2, Period 3: Days -1 to 5, and 7; Part 2, Period 4: Days -1 to 5, 7, and 18

descriptive

Secondary/protocol endpoint

Part 1: Plasma Concentrations of Itraconazole and Hydroxy-Itraconazole Over Time

Time frame:Part 1, Period 2: Days -3 to 2, 4, 6, 8, and 14

concentration, descriptive

Secondary/protocol endpoint

Part 2: Plasma Concentrations of Gemfibrozil Over Time

Time frame:Part 2, Period 2: Days -1 to 2, and 4

concentration, descriptive

Secondary/protocol endpoint

Incidence and Severity of Adverse Events

Time frame:Part 1: from first study treatment until safety follow-up visit (37 days); Part 2: from first study treatment until safety follow-up visit (56 days)

descriptive

Secondary/protocol endpoint

Incidence of Abnormal Clinical Laboratory Test Findings

Time frame:Part 1: from first study treatment until safety follow-up visit (37 days); Part 2: from first study treatment until safety follow-up visit (56 days)

event count, event

Secondary/protocol endpoint

Incidence of Abnormal Vital Signs

Time frame:Part 1: from first study treatment until safety follow-up visit (37 days); Part 2: from first study treatment until safety follow-up visit (56 days)

event count, event

Secondary/protocol endpoint

Incidence of Electrocardiogram (ECG) Parameter Abnormalities

Time frame:Part 1: from first study treatment until safety follow-up visit (37 days); Part 2: from first study treatment until safety follow-up visit (56 days)

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Part 2: Blood Concentrations of Cyclosporine Over Time

Time frame:Part 2, Period 3: Days 1 to 5, and 7; Part 2, Period 4: Days 1 to 5, and 7

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.