A Phase 1 interventional study of Experimental: Cotadutide and Placebo in Diabetes, sponsored by AstraZeneca. Completed at 2 sites in China. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
A Phase 1 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Cotadutide in Overweight/Obese Subjects with Chinese ancestry with Type 2 Diabetes Mellitus
This is a randomized, double-blinded, placebo-controlled study designed to evaluate the safety, tolerability, PK and efficacy of ascending doses of cotadutide in overweight or obese subjects with T2DM. This study will enroll subjects aged 18 to 74 years with a body mass index (BMI) ≥ 25 and ≤ 35 kg/m2. Subjects will have a diagnosis of T2DM and inadequate blood glucose control as defined by a HbA1c of 7% to 8.5%, and will be on metformin monotherapy in the three months prior to screening. Total 16 Chinese subjects will be randomized to cotadutide or placebo in a 3:1 ratio (cotadutide [n=12] and placebo [n=4]) at multicentre in China mainland. Those subjects who receive cotadutide once daily SC will be titrated to a maximum of 600 μg once daily SC, beginning at 50 μg once daily SC. The study has about 2 weeks screening period, a run-in period of 10 days and an up to 7-week up-titration treatment period followed by a 3-week treatment extension period at the dose of 600 μg and followed by a 28-day follow-up period.
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This study's enrollment of 16 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria
Any subject who has received any of the following medications within the specified timeframe prior to the start of the study
Significant hepatic disease (except for NASH or NAFLD without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening:
Poorly controlled hypertension defined as:
Those subjects who were randomized to cotadutide once daily SC will begin at 50 μg once daily, then up-titrated to 100 μg once daily a week later, after that up-titration will be done at 100 μg increment weekly, till to a maximum of 600 μg once daily.
Drug: Experimental: Cotadutide
Placebo: Placebo subcutaneous injection
Other: Placebo
Cotadutide: subcutaneous (SC) injection
Placebo subcutaneous injection
Incidence of treatment-emergent adverse events (TEAEs)
To assess the safety and tolerability of Cotadutide
Time frame: Baseline until the follow-up period (28 days post last dose), 98 days in total
Incidence of treatment-emergent serious adverse events (TESAEs)
To assess the safety and tolerability of Cotadutide
Time frame: 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
Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, QT intervals, and QTcF intervals as measured by digitial 12-lead ECG.
Time frame: 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
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital sign parameters (Systolic Blood Pressure, Diastolic Blood Pressure, Pulse, Respiration rate, body temperature).
Time frame: 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
Number of participants with abnormal physical examinations reported as TEAEs are reported. Abnormal physical examinations findings are defined as any abnormal finding in the following body systems: immunologic/allergy; head, ears, eyes, nose and throat; respiratory; cardiovascular; gastrointestinal; musculoskeletal; neurological psychiatric; dermatologic; hematologic/lymphatic; and enocrine.
Time frame: 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)
To characterize the PK profile of Cotadutide
Time frame: Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
Maximum observed concentration (Cmax)
To characterize the PK profile of Cotadutide
Time frame: Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
Time to Cmax (tmax)
To characterize the PK profile of Cotadutide
Time frame: Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
Trough plasma concentration (Ctrough)
To characterize the PK profile of Cotadutide
Time frame: 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
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urinalysis.
Time frame: Baseline until the follow-up period (28 days post last dose), 98 days in total
Anti-drug antibodies (ADAs) to Cotadutide
To characterize the immunogenicity of Cotadutide
Time frame: Day 1 of Up-titration treatment period through end of study, 98 days in total
Change in daily average glucose levels
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Time frame: baseline to the end of extension period, and during 14 days of the follow up period, 84 days in total.
Change in 7-day average glucose levels
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Time frame: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
Change in percentage time spent in hyperglycemia (> 140 mg/dL) over 24hours and over 7days
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Time frame: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
Change in percentage time spent in target range (70 -140 mg/dL) over 24hours and over 7days
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Time frame: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
Change in percentage time spent in the range (< 54 mg/dL) over 24hours and over 7days
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Time frame: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
Change in estimated hemoglobin A1c (HbA1c)
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Time frame: Baseline through 21day treatment extension period, 70 days in total
Change in fasting plasma glucose (mg/dL)
To assess the effects of cotadutide, titrated up to the dose of 600 μg, on additional measures of glucose control
Time frame: Baseline through 21day treatment extension period, 70 days in total
Change in HbA1c
To assess the effects of cotadutide, titrated up to the dose of 600 μg, on additional measures of glucose control
Time frame: Baseline through 21day treatment extension period, 70 days in total
Percentage change in body weight
To assess the effects of cotadutide, titrated up to the dose of 600 μg, on body weight
Time frame: Baseline through 21day treatment extension period, 70 days in total
Absolute change in body weight
To assess the effects of cotadutide, titrated up to the dose of 600 μg, on body weight
Time frame: Baseline through 21day treatment extension period, 70 days in total
Proportion of subjects achieving > 5% body weight loss
To assess the effects of cotadutide, titrated up to the dose of 600 μg, on body weight
Time frame: Baseline through 21day treatment extension period, 70 days in total
Change in coefficient of variation as measured by CGM over 7 days
To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM)
Time frame: Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Sap
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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