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COTA China PK
CompletedPhase 1Chinese Multiple Dose Escalation (MDE) High Dose Study
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
Lead sponsor
Asset
Cotadutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
2
Recruiting sites
—
Enrollment
16
actual
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criteria
•BMI 25-35•HbA1c 7-8.5%
Primary endpoints
•Treatment-emergent AEs (any)•Serious AEs (any)•AUC during the dosing interval (AUCtau)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Subjects aged 18 to 74 years
2. Provision of signed and dated written informed consent prior to any study specific procedures
3. BMI between 25 and 35 kg/m2
4. HbA1c range of 7% to 8.5%
5. Willing and able to self-inject investigational product
6. Diagnosed with T2DM with glucose control managed with metformin monotherapy where no significant dose change has occurred in the three months prior to screening.
7. Women of child-bearing potential who are sexually active with a male partner must be using at least one highly effective method of contraception. And must have a negative serum or urine pregnancy test within 72 hours prior to the start of IP, and must not be breastfeeding.
Exclusion criteria
1. Any subject who has received another IP as part of a clinical study or a GLP-1 analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening
2. Concurrent participation in another randomization study of any kind; repeat randomization is prohibited
3. Any subject who has received any of the following medications within the specified timeframe prior to the start of the study
4. Symptoms of acutely decompensated blood glucose control, recent severe hypoglycemia, a history of T1DM orDKA
5. Acute pancreatitis at screening or history of acute pancreatitis or chronic pancreatitis or serum triglyceride levels > 11 mmol/L at screening
6. Significant inflammatory bowel disease, gastroparesis or other severe disease or surgery affecting the upper GI tract, which may affect gastric emptying or could affect the interpretation of safety and tolerability data
7. Significant hepatic disease (except for NASH or NAFLD without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening:
8. Impaired renal function defined as eGFR< 30 mL/minute/1.73m2 at screening
9. Poorly controlled hypertension defined as:
10. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead ECG or any abnormalities that may interfere with the interpretation of serial ECG changes, including QTc interval changes at screening, as judged by the investigator, and prolonged QTcF > 450 ms, or family history of long QT-segment at screening
11. PR (PQ) interval prolongation, intermittent second (Wenckebach block while asleep is not exclusive), or third-degree AV block, or AV dissociation
12. Persistent or intermittent complete bundle branch block.
13. Unstable angina pectoris, myocardial infarction, transient ischemic attack, or stroke within 3 months prior to screening, or subjects who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to undergo these procedures at the time of screening
14. Severe congestive heart failure (NYHA Class III or IV)
15. Basal calcitonin level ≥ 50 ng/L at screening or history/family history of medullary thyroid carcinoma or MEN2
16. History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or in situ cervical cancer
17. Any positive results for serum hepatitis B surface antigen, hepatitis C antibody, and HIV antibody
18. History of substance dependence, alcohol abuse, or excessive alcohol intake within 3 years prior to screening and/or a positive screen for drugs of abuse or alcohol at screening or on admission to the study unit.
19. Symptoms of depression or any other psychiatric disorder requiring treatment with medication (eg, anti-depressants, anti-psychotics) at screening. However, subjects who use benzodiazepines for chronic anxiety or sleep disorders may be permitted to enter the study.
20. History of severe allergy/hypersensitivity, including to any component of the investigational product formulation or other biological agent, or ongoing clinically important allergy/hypersensitivity as judged by the investigator
21. Blood/plasma donation within 1 month of screening
22. Involvement of any AstraZeneca, the contract research organization, or the virtual study site employee or their close relatives
23. For women only- currently pregnant (confirmed with positive pregnancy test) or breastfeeding
Endpoints (23)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
3 endpointsPercentage change in body weight
Time frame:Baseline through 21day treatment extension period, 70 days in total
Body weight, % change
percent change from baseline, improvement
Absolute change in body weight
Time frame:Baseline through 21day treatment extension period, 70 days in total
Body weight, absolute change (kg)
change from baseline, improvement
Proportion of subjects achieving > 5% body weight loss
Time frame:Baseline through 21day treatment extension period, 70 days in total
≥5% weight-loss responders
threshold achievement, improvement
Glycemic / diabetes
9 endpointsChange in daily average glucose levels
Time frame:baseline to the end of extension period, and during 14 days of the follow up period, 84 days in total.
change from baseline, improvement
Change in 7-day average glucose levels
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 from baseline, improvement
Change in percentage time spent in hyperglycemia (> 140 mg/dL) over 24hours and over 7days
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
CGM time-above-range
change from baseline, improvement
Change in percentage time spent in target range (70 -140 mg/dL) over 24hours and over 7days
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
CGM time-in-range
change from baseline, improvement
Change in percentage time spent in the range (< 54 mg/dL) over 24hours and over 7days
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
CGM time-below-range
change from baseline, improvement
Change in estimated hemoglobin A1c (HbA1c)
Time frame:Baseline through 21day treatment extension period, 70 days in total
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in fasting plasma glucose (mg/dL)
Time frame:Baseline through 21day treatment extension period, 70 days in total
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in HbA1c
Time frame:Baseline through 21day treatment extension period, 70 days in total
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in coefficient of variation as measured by CGM over 7 days
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 from baseline, improvement
Safety / tolerability / PK
11 endpointsIncidence of treatment-emergent adverse events (TEAEs)
Time frame:Baseline until the follow-up period (28 days post last dose), 98 days in total
Treatment-emergent AEs (any)
event count, event
Incidence of treatment-emergent serious adverse events (TESAEs)
Time frame:Baseline until the follow-up period (28 days post last dose), 98 days in total
Serious AEs (any)
event count, event
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs
Time frame:Baseline until the follow-up period (28 days post last dose), 98 days in total
Treatment-emergent AEs (any)
event count, event
Number of participants with abnormal vital signs reported as TEAEs
Time frame:Baseline until the follow-up period (28 days post last dose), 98 days in total
Treatment-emergent AEs (any)
event count, event
Number of Participants With Abnormal Physical Examinations Reported as TEAEs
Time frame:Baseline until the follow-up period (28 days post last dose), 98 days in total
Treatment-emergent AEs (any)
event count, event
Area under the concentration-time curve (AUC) during the dosing interval (AUCtau)
Time frame:Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
AUC₀–∞
concentration, descriptive
Maximum observed concentration (Cmax)
Time frame:Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
Cmax
concentration, descriptive
Time to Cmax (tmax)
Time frame:Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
Tmax
descriptive
Trough plasma concentration (Ctrough)
Time frame:Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.
Plasma concentration (steady state)
concentration, descriptive
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Time frame:Baseline until the follow-up period (28 days post last dose), 98 days in total
Treatment-emergent AEs (any)
event count, event
Anti-drug antibodies (ADAs) to Cotadutide
Time frame:Day 1 of Up-titration treatment period through end of study, 98 days in total
Immunogenicity (ADA)
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.