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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• 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%
Locations
Other Locations
Australia
Nucleus Network Pty Ltd.
COMPLETED
Melbourne
Mexico
Avant Santé Research Center S.A. de C.V.
RECRUITING
San Pedro Garza García
Time Frame
Start Date: 2023-05-09
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 94
Treatments
Experimental: Part 1: CT-996 SAD Cohort 1
Experimental: Part 1: CT-996 SAD Cohort 2
Experimental: Part 1: CT-996 SAD Cohort 3, Then SAD Cohort 5
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.
Experimental: Part 1: CT-996 SAD Cohort 4
Experimental: Part 1: CT-996 SAD Cohort 6
Placebo_comparator: Part 1: Placebo SAD Cohort
Experimental: Part 2: CT-996 MAD Cohort 1
Experimental: Part 2: CT-996 MAD Cohort 2
Experimental: Part 2: CT-996 MAD Cohort 3
Placebo_comparator: Part 2: Placebo MAD Cohort
Experimental: Part 3: CT-996 MD T2DM Cohort 1
Experimental: Part 3: CT-996 MD T2DM Cohort 2
Placebo_comparator: Part 3: Placebo MD T2DM Cohort
Related Therapeutic Areas
Sponsors
Collaborators: Hoffmann-La Roche, Carmot Therapeutics, Inc.
Leads: Carmot Australia First Pty Ltd