Overweight or Obesity, Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Obesity, Overweight
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.
Interventions
DRUGCT-996
Capsule of CT-996
DRUGPlacebo
Capsule of placebo matching CT-996.
Sponsors
Carmot Therapeutics, Inc.
Hoffmann-La Roche
Carmot Australia First Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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%
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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) | — |
| 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 | — |
| 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 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 |
| Part 1 Cohorts: Volume of Distribution (V) of CT-996 | At prespecified timepoints from Day 1 to Day 5 | — |
Countries
Australia, Mexico
Outcome results
None listed