← Trials/Trial dossier/NCT05814107
Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus
A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CT-996 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus
Lead sponsor
Asset
CT-996 / RO7795081
Oral · GLP-1 agonist
Listed sites
2
Recruiting sites
—
Enrollment
94
actual
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criteria
•BMI 25-40•HbA1c 7-10%
Primary endpoint
•Treatment-Emergent Adverse Events
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Additional Inclusion Criterion for Part 3 (MD T2DM cohorts) only:
Exclusion criteria
Endpoints (13)
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.
Safety / tolerability / PK
13 endpointsIncidence of Treatment-Emergent Adverse Events
Time frame:From first study drug administration until last safety follow-up (up to 31 days [Part 1] or 58 days [Parts 2 and 3])
event count, event
Maximum Observed Plasma Concentration (Cmax) of CT-996
Time frame:At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
concentration, descriptive
Time to Maximum Observed Plasma Concentration (Tmax) of CT-996
Time frame:At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
time to event, event
Area Under the Concentration-Time Curve (AUC) from Time 0 to the Time of Last Measurable Concentration (AUC0-t) of CT-996
Time frame:At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
concentration, descriptive
AUC from Time 0 Extrapolated to Infinity (AUC0-inf) of CT-996
Time frame:At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
concentration, descriptive
Apparent Terminal Elimination Half-Life (t1/2) of CT-996
Time frame:At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
concentration, descriptive
Part 1 Cohorts: Clearance (CL) of CT-996
Time frame:At prespecified timepoints from Day 1 to Day 5
concentration, descriptive
Part 1 Cohorts: Volume of Distribution (V) of CT-996
Time frame:At prespecified timepoints from Day 1 to Day 5
descriptive
Part 2 Cohorts: Minimum Observed Plasma Concentration (Cmin) of CT-996
Time frame:At prespecified timepoints from Day 1 to Day 33
concentration, descriptive
Parts 2 and 3 Cohorts: Clearance Divided by the Bioavailable Fraction (CL/F) of CT-996
Time frame:At prespecified timepoints from Day 1 to Day 33
concentration, descriptive
Parts 2 and 3 Cohorts: Volume of Distribution Divided by the Bioavailable Fraction (Vz/F) of CT-996
Time frame:At prespecified timepoints from Day 1 to Day 33
descriptive
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on Cmax of CT-996
Time frame:At prespecified timepoints for up to 14 days
concentration, descriptive
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on AUC of CT-996
Time frame:At prespecified timepoints for up to 14 days
concentration, descriptive
Provenance
Sources
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.