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

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.

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