Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus
- Conditions
- Type 2 DiabetesOverweight or Obesity
- Interventions
- Drug: Placebo
- Registration Number
- NCT05814107
- Lead Sponsor
- Carmot Australia First Pty Ltd
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 94
- Participants 18-65 years old, inclusive
- BMI of 25 - 40, inclusive
- Stable body weight for two months
Additional Inclusion Criterion for Part 3 (MD T2DM cohorts) only:
- Participants in Part 3 should have a documented diagnosis of Type 2 Diabetes Mellitus (T2DM)
- Participants in Part 3 should have glycated hemoglobin (HbA1c) between 7.0% and 10.0%
- History of significant medical conditions and malignancy
- Uncontrollable hypertension
- History of alcoholism or drug addiction within 1 year prior to Screening
- Current or recent participation in an investigational clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: CT-996 SAD Cohort 1 CT-996 - Part 1: CT-996 SAD Cohort 2 CT-996 - Part 1: CT-996 SAD Cohort 3, Then SAD Cohort 5 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. Part 1: CT-996 SAD Cohort 4 CT-996 - Part 1: CT-996 SAD Cohort 6 CT-996 - Part 1: Placebo SAD Cohort Placebo - Part 2: CT-996 MAD Cohort 1 CT-996 - Part 2: CT-996 MAD Cohort 2 CT-996 - Part 2: CT-996 MAD Cohort 3 CT-996 - Part 2: Placebo MAD Cohort Placebo - Part 3: CT-996 MD T2DM Cohort 1 CT-996 - Part 3: CT-996 MD T2DM Cohort 2 CT-996 - Part 3: Placebo MD T2DM Cohort Placebo -
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events From first study drug administration until last safety follow-up (up to 31 days [Part 1] or 58 days [Parts 2 and 3])
- Secondary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of CT-996 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 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 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 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 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 At prespecified timepoints from Day 1 to Day 5 Part 1 Cohorts: Volume of Distribution (V) of CT-996 At prespecified timepoints from Day 1 to Day 5 Parts 2 and 3 Cohorts: Volume of Distribution Divided by the Bioavailable Fraction (Vz/F) of CT-996 At prespecified timepoints from Day 1 to Day 33 Part 2 Cohorts: Minimum Observed Plasma Concentration (Cmin) of CT-996 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 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 At prespecified timepoints for up to 14 days Determine the effect of a high-fat meal on the PK of CT-996 following a single dose
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on AUC of CT-996 At prespecified timepoints for up to 14 days Determine the effect of a high-fat meal on the PK of CT-996 following a single dose
Trial Locations
- Locations (2)
Nucleus Network Pty Ltd.
🇦🇺Melbourne, Australia
Avant Santé Research Center S.A. de C.V.
🇲🇽San Pedro Garza García, Mexico
Nucleus Network Pty Ltd.🇦🇺Melbourne, Australia