A Phase 1 interventional study of CT-996 and Placebo in Type 2 Diabetes and Overweight or Obesity, sponsored by Carmot Australia First Pty Ltd. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Carmot Australia First Pty Ltd · Phase 1, Interventional, and Treatment
This study is designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with Type 2 Diabetes Mellitus (T2DM).
This is a multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 when administered as single ascending doses (SAD) and multiple-ascending doses (MAD) in overweight/obese participants and as multiple doses (MD) in patients with T2DM.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 94 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →This is the only study on the registry with Carmot Australia First Pty Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Additional Inclusion Criterion for Part 3 (MD T2DM cohorts) only:
Exclusion Criteria:
Drug: CT-996
Drug: CT-996
During SAD Cohort 3, participants will be dosed under fasted conditions. During SAD Cohort 5, the same participants will receive the same dose under high-fat fed conditions.
Drug: CT-996
Drug: CT-996
Drug: CT-996
Drug: Placebo
Drug: CT-996
Drug: CT-996
Drug: CT-996
Drug: Placebo
Drug: CT-996
Drug: CT-996
Drug: Placebo
Capsule of CT-996
Also known as: RO7795081, RG6652
Capsule of placebo matching CT-996.
Incidence 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])
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)
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)
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)
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)
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)
Part 1 Cohorts: Clearance (CL) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5
Part 1 Cohorts: Volume of Distribution (V) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5
Part 2 Cohorts: Minimum Observed Plasma Concentration (Cmin) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 33
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
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
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on Cmax of CT-996
Determine the effect of a high-fat meal on the PK of CT-996 following a single dose
Time frame: At prespecified timepoints for up to 14 days
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on AUC of CT-996
Determine the effect of a high-fat meal on the PK of CT-996 following a single dose
Time frame: At prespecified timepoints for up to 14 days
Plan to share: No
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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