GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus

A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled, and Open-label Comparator Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Assets

Cotadutide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

248

actual

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c 6.5-12.5%•eGFR 20-90•UACR ≥50

Primary endpoint

•UACR, % change

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

NCT IDNCT04515849

Org study IDD5676C00001

Secondary ID2020-000255-12

Timeline

Milestones

Study first posted2020-08-17actual

Study start2020-08-31actual

Primary completion2022-03-08actual

Study completion2022-03-08actual

Last update posted2025-01-17actual

Results first posted2025-01-17actual

Assets

Investigational agents

Cotadutide Semaglutide

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age79 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Estimated glomerular filtration rate ≥ 20 to < 90 mL/min/1.73 m2 determined at the screening visit or a documented occurrence in medical history at least 3 months prior to randomisation.

•Receiving background standard of care treatment for renal disease and/or T2DM and being treated according to locally recognised guidelines, as appropriate.

•Receiving optimised and stable treatment with an angiotensin-converting-enzyme (ACE) inhibitor or an angiotensin II receptor antagonist for ≥ 3 months at screening at the maximum tolerated dose (MTD) unless contraindicated, not tolerated, or in the opinion of the investigator, not practically available or suitable.

•Micro- or macroalbuminuria as defined by UACR > 50 mg/g or 5.7 mg/mmol.

•Diagnosed with T2DM with glucose control managed with any insulin and/or any oral therapy combination including metformin, SGLT2 inhibitor, thiazolidinedione, or acarbose where no major dose changes (eg, > 50% increase in dose) have occurred within the 4 weeks prior to the start of the run-in period. Participants taking sulfonylureas or glitinides may be randomised following a 4-week washout period of the sulfonylurea/glitinide.

•Haemoglobin A1c range of 6.5 % to 12.5% (inclusive) at screening

•Body mass index > 25 kg/m2 at screening or > 23 kg/m2 for participants enrolled in Japan

Exclusion criteria

•History or presence of significant medical or psychological conditions, including significant abnormalities in laboratory parameters or vital signs including ECG, which in the opinion of the investigator, would compromise the participant's safety or successful participation in the study.

•Receiving renal replacement therapy or expected to require it within 6 months of being randomised

•Renal transplant or on the waiting list for renal transplantation

•Received a GLP-1 analogue-containing preparation within the last 30 days or 5 half-lives of the drug, if known (whichever is longer), at the time of Visit 2

•Received any of the following medications within the specified time frame prior to the start of the study (Visit 2):

1. Aspirin (acetylsalicylic acid) at a dose greater than 150 mg once daily and within the last 3 days prior to the start of the run-in period (Visit 2)

2. Paracetamol (acetaminophen) or paracetamol-containing preparations at a total daily dose of greater than 3000 mg and within the last 3 days prior to the start of the run-in period (Visit 2)

3. Ascorbic acid (vitamin C) supplements at a total daily dose of greater than 1000 mg and within the last 3 days prior to the start of the run-in period (Visit 2)

•Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives of the drug, if known (whichever is longer)

•Participants with a known severe allergy/hypersensitivity to any of the proposed study interventions or excipients of the product

•Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss) or recent episodes of severe hypoglycaemia

•Type 1 diabetes mellitus (T1DM), history of diabetic ketoacidosis, or clinical suspicion of T1DM

•Participants with recent acute or subacute renal function deterioration

•Significant inflammatory bowel disease, gastroparesis, or other severe disease or surgery affecting the upper gastrointestinal tract (including weight-reducing surgery and procedures) which may affect gastric emptying or could affect the interpretation of safety and tolerability data

•History of acute or chronic pancreatitis

•Significant hepatic disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results:

1. Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN)

2. Alanine transaminase (ALT) ≥ 3 × ULN

3. Total bilirubin ≥ 2 × ULN

•Poorly controlled hypertension defined as:

1. Systolic BP > 180 mm Hg

2. Diastolic BP ≥ 90 mm Hg after 10 minutes of seated rest and confirmed by repeated measurement at screening. Participants who fail BP screening criteria may be considered for 24-hour ambulatory BP monitoring at the discretion of the investigator. Participants who maintain a mean 24-hour systolic BP ≤ 180 or diastolic BP < 90 mm Hg with a preserved nocturnal dip of > 15% will be considered eligible

•Unstable angina pectoris, myocardial infarction, transient ischemic attack or stroke within 3 months prior to screening, or participants 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

•Decompensated heart failure or hospitalisation for heart failure in the 3 months prior to screening or symptoms consistent with New York Heart Association heart failure Class III/IV

•Basal calcitonin level > 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia

•History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer

Endpoints (24)

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

Glycemic / diabetes

Weight & body composition

Renal / kidney

Weight & body composition

4 endpoints

Secondary/registry result

Percent Change in Body Weight of Cotatudide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing

Time frame:Baseline to end of 14 weeks of dosing

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage change	95% CI
Cotadutide 100 ug	-2.84	—
Cotadutide 300 µg	-4.15	—
Cotadutide 600 µg	-5.40	—
Placebo ug	-1.61	—

Secondary/registry result

Percentage Change in Body Weight of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing

Time frame:Baseline to end of 26 weeks of dosing

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage change	95% CI
Cotadutide 100 ug	-2.60	—
Cotadutide 300 µg	-5.45	—
Cotadutide 600 µg	-7.35	—
Placebo ug	-2.23	—

Secondary/protocol endpoint

Percent Change in Body Weight of Cotatudide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing

Time frame:Baseline to end of 14 weeks of dosing

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage Change in Body Weight of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing

Time frame:Baseline to end of 26 weeks of dosing

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

16 endpoints

Secondary/registry result

Percent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 14 of Dosing

Time frame:Baseline to end of 14 weeks of dosing

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Cotadutide 100 µg	-0.76	—
Cotadutide 300 µg	-0.82	—
Cotadutide 600 µg	-0.65	—
Placebo ug	-0.08	—

Secondary/registry result

Percent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 26 of Dosing

Time frame:Baseline to end of 26 weeks of dosing

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Cotadutide 100 µg	-0.92	—
Cotadutide 300 µg	-0.92	—
Cotadutide 600 µg	-0.89	—
Placebo ug	-0.25	—

Secondary/registry result

Change in Fasting Glucose of Cotadutide at Different Dose Levels From Baseline Versus Placebo After 14 Weeks of Dosing

Time frame:Baseline to end of 14 weeks of dosing

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Cotadutide 100 ug	-1.35	—
Cotadutide 300 µg	-1.57	—
Cotadutide 600 µg	-1.69	—
Placebo ug	-0.54	—

Secondary/registry result

Change in Fasting Glucose of Cotadutide at Different Dose Levels From Baseline Versus Placebo After 26 Weeks of Dosing

Time frame:Baseline to end of 26 weeks of dosing

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Cotadutide 100 ug	-1.78	—
Cotadutide 300 µg	-1.76	—
Cotadutide 600 µg	-1.57	—
Placebo ug	-0.72	—

Secondary/registry result

Change in 10-day Average Glucose Levels of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing

Time frame:Baseline to end of 14 weeks of dosing

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Cotadutide 100 ug	-1.556	—
Cotadutide 300 µg	-1.478	—
Cotadutide 600 µg	-1.269	—
Placebo ug	-0.440	—

Secondary/registry result

Change in 10-day Average Glucose Levels of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing

Time frame:Baseline to end of 26 weeks of dosing

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Cotadutide 100 ug	-1.735	—
Cotadutide 300 µg	-1.446	—
Cotadutide 600 µg	-1.118	—
Placebo ug	-0.273	—

Secondary/registry result

Change in Percentage Time Spent in Hyperglycaemia Over 10 Days of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks of Dosing

Time frame:Baseline to 14 weeks of dosing

CGM time-above-range

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent Change	95% CI
Cotadutide 100 ug	-13.87	—
Cotadutide 300 µg	-15.79	—
Cotadutide 600 µg	-13.90	—
Placebo ug	-4.09	—

Secondary/registry result

Change in Percentage Time Spent in Hyperglycaemia Over 10 Days of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks of Dosing

Time frame:Baseline to 26 weeks of dosing

CGM time-above-range

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Cotadutide 100 ug	-18.06	—
Cotadutide 300 µg	-15.38	—
Cotadutide 600 µg	-11.91	—
Placebo ug	-3.00	—

Secondary/protocol endpoint

Percent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 14 of Dosing

Time frame:Baseline to end of 14 weeks of dosing

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 26 of Dosing

Time frame:Baseline to end of 26 weeks of dosing

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Glucose of Cotadutide at Different Dose Levels From Baseline Versus Placebo After 14 Weeks of Dosing

Time frame:Baseline to end of 14 weeks of dosing

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Fasting Glucose of Cotadutide at Different Dose Levels From Baseline Versus Placebo After 26 Weeks of Dosing

Time frame:Baseline to end of 26 weeks of dosing

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in 10-day Average Glucose Levels of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing

Time frame:Baseline to end of 14 weeks of dosing

change from baseline, improvement

Secondary/protocol endpoint

Change in 10-day Average Glucose Levels of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing

Time frame:Baseline to end of 26 weeks of dosing

change from baseline, improvement

Secondary/protocol endpoint

Change in Percentage Time Spent in Hyperglycaemia Over 10 Days of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks of Dosing

Time frame:Baseline to 14 weeks of dosing

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Percentage Time Spent in Hyperglycaemia Over 10 Days of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks of Dosing

Time frame:Baseline to 26 weeks of dosing

CGM time-above-range

percent change from baseline, improvement

Renal / kidney

4 endpoints

Primary/registry result

The Primary Endpoint Was Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks

Time frame:Baseline to the end of 14 weeks of dosing

uACR, % change

percent change from baseline, improvement

LOINC 9318-7

Posted result

Group	Value (geometric_least_squares_mean), Percentage change	95% CI
Cotadutide 100 ug	-10.96	-29.60 – 12.61
Cotadutide 300 µg	-40.47	-53.00 – -24.60
Cotadutide 600 µg	-44.60	-56.21 – -29.91
Placebo ug	4.60	-18.02 – 33.46

Primary/protocol endpoint

The Primary Endpoint Was Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks

Time frame:Baseline to the end of 14 weeks of dosing

uACR, % change

percent change from baseline, improvement

LOINC 9318-7

Secondary/registry result

Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks

Time frame:Baseline to end of 26 weeks of dosing

uACR, % change

percent change from baseline, improvement

LOINC 9318-7

Posted result

Group	Value (geometric_least_squares_mean), Percentage change	95% CI
Cotadutide 100 ug	-17.85	-45.47 – 23.78
Cotadutide 300 µg	-38.68	-59.61 – -6.88
Cotadutide 600 µg	-57.87	-73.33 – -33.45
Placebo ug	11.79	-27.85 – 73.22

Secondary/protocol endpoint

Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks

Time frame:Baseline to end of 26 weeks of dosing

uACR, % change

percent change from baseline, improvement

LOINC 9318-7

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Pharmacokinetic-pharmacodynamic (PK/PD) modelling of cotadutide effect in patients with chronic kidney disease and type 2 diabetes mellitus.
British journal of clinical pharmacology2025 Sep (month)PMID40344607doi:10.1002/bcp.70093via clinicaltrials gov reference derived + pubmed nct search
Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
A randomized phase 2b trial examined the effects of the glucagon-like peptide-1 and glucagon receptor agonist cotadutide on kidney outcomes in patients with diabetic kidney disease.
Kidney international2024 Dec (month)PMID39218393doi:10.1016/j.kint.2024.08.023via CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.