| Trial ID: | L7083 |
| Source ID: | NCT04838405
|
| Associated Drug: |
Ct-388
|
| Title: |
A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients with Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes
|
| Interventions: |
DRUG: CT-388|DRUG: Placebo
|
| Outcome Measures: |
Primary: Incidence of Treatment-Emergent Adverse Events as assessed by self-report, Safety and tolerability, Baseline up to 24 weeks | Secondary: Area under the concentration versus time curve (AUC), PK AUC, Baseline up to 24 weeks|Maximum observed drug concentration (Cmax), PK Cmax, Baseline up to 24 weeks|Elimination half-life, PK t1/2, Baseline up to 24 weeks|Change in mean body weight, PD body weight, Baseline up to 24 weeks|Change in mean glucose levels, PD glucose, Baseline up to 24 weeks|Change in mean insulin levels, PD insulin, Baseline up to 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Carmot Therapeutics, Inc. | Collaborators: Carmot Australia First Pty Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
129
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-07-29
|
| Completion Date: |
2024-08-02
|
| Results First Posted: |
|
| Last Update Posted: |
2025-02-14
|
| Locations: |
Carmot Clinical Research Unit 101, Perth, Western Australia, 6009, Australia|Carmot Clinical Research Unit 105, Monterrey, Nuevo Leon, 66260, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT04838405
|
