A Phase 1 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Cotadutide in Chinese Overweight/Obese Subjects With Type 2 Diabetes Mellitus

Registration

Registration

NCT05437848

Acronym

COTA China PK

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

TRIPLE

Status

COMPLETED

Enrollment

16

Start

2022-02-25

Primary completion

2022-12-12

Lead sponsor

AstraZeneca

Conditions

Diabetes

Interventions

DRUG:Experimental: Cotadutide; OTHER:Placebo

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Incidence of treatment-emergent adverse events (TEAEs) [Baseline until the follow-up period (28 days post last dose), 98 days in total]
• Incidence of treatment-emergent serious adverse events (TESAEs) [Baseline until the follow-up period (28 days post last dose), 98 days in total]
• Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs [Baseline until the follow-up period (28 days post last dose), 98 days in total]
• Number of participants with abnormal vital signs reported as TEAEs [Baseline until the follow-up period (28 days post last dose), 98 days in total]
• Number of Participants With Abnormal Physical Examinations Reported as TEAEs [Baseline until the follow-up period (28 days post last dose), 98 days in total]
• Area under the concentration-time curve (AUC) during the dosing interval (AUCtau) [Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.]
• Maximum observed concentration (Cmax) [Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.]
• Time to Cmax (tmax) [Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.]
• Trough plasma concentration (Ctrough) [Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.]
• Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs [Baseline until the follow-up period (28 days post last dose), 98 days in total]