This is a first-in-human evaluation of CT-388 in a double blind, placebo controlled, randomized, SAD/MAD/MD, safety, tolerance, PK, and PD study when administered as a SC injection in otherwise healthy overweight and obese adult participants and obese participants with T2DM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
129
Carmot Clinical Research Unit 101
Perth, Western Australia, Australia
Carmot Clinical Research Unit 105
Monterrey, Nuevo León, Mexico
Incidence of Treatment-Emergent Adverse Events as assessed by self-report
Safety and tolerability
Time frame: Baseline up to 24 weeks
Area under the concentration versus time curve (AUC)
PK AUC
Time frame: Baseline up to 24 weeks
Maximum observed drug concentration (Cmax)
PK Cmax
Time frame: Baseline up to 24 weeks
Elimination half-life
PK t1/2
Time frame: Baseline up to 24 weeks
Change in mean body weight
PD body weight
Time frame: Baseline up to 24 weeks
Change in mean glucose levels
PD glucose
Time frame: Baseline up to 24 weeks
Change in mean insulin levels
PD insulin
Time frame: Baseline up to 24 weeks
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