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CompletedNCT04515849Updated Jan 17, 2025Results posted

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

A Phase 2 interventional study of Cotadutide 100 micrograms and Cotadutide 300 micrograms in Type 2 Diabetes Mellitus and Chronic Kidney Diseases, sponsored by AstraZeneca. Completed at 83 sites in 8 countries. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
248
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

A Phase 2b, study to measure the effect of Cotadutide at different doses versus placebo or comparator (semaglutide) in participants who have Chronic Kidney Disease with Type 2 Diabetes Mellitus.

Read the detailed description

A Phase 2b randomised, double-blind, placebo-controlled and open-label active comparator study to evaluate the effect of Cotadutide at 100, 300 or 600 micrograms in participants who have Chronic Kidney Disease with Type 2 Diabetes Mellitus.

The study plans to randomise approximately 225 subjects. Subjects will be randomised to receive double-blind Cotadutide or placebo at 100, 300 or 600 micrograms once daily for 26 weeks, or open-label semaglutide at 1.0 miligrams once a week for 26 weeks. Japanese participants will not be randomised to the semaglutide arm.

02

Conditions studied

  • Type 2 Diabetes Mellitus
  • Chronic Kidney Diseases

Keywords

  • MEDI0382
  • T2DM
  • Cotadutide
  • Diabetic Kidney Disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 248 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
248 participants (actual)

Study arms

  • Experimental
    Cotadutide 100 micrograms

    Cotadutide 100 micrograms administered subcutaneously

    Drug: Cotadutide 100 micrograms

  • Experimental
    Cotadutide 300 micrograms

    Cotadutide 300 micrograms administered subcutaneously

    Drug: Cotadutide 300 micrograms

  • Experimental
    Cotadutide 600 micrograms

    Cotadutide 600 micrograms administered subcutaneously

    Drug: Cotadutide 600 micrograms

  • Placebo comparator
    Placebo

    Placebo administered subcutaneously

    Drug: Placebo

  • Active comparator
    Semaglutide

    Semaglutide 1.0 miligrams administered subcutaneously

    Drug: Semaglutide

Interventions

  • DrugCotadutide 100 micrograms

    Cotadutide 100 micrograms administered subcutaneously

    Also known as: MEDI0382

  • DrugCotadutide 300 micrograms

    Cotadutide 300 micrograms administered subcutaneously

    Also known as: MEDI0382

  • DrugCotadutide 600 micrograms

    Cotadutide 600 micrograms administered subcutaneously

    Also known as: MEDI0382

  • DrugSemaglutide

    Semaglutide 1.0 miligrams administered subcutaneously

    Also known as: Ozempic

  • DrugPlacebo

    Placebo administered subcutaneously

06

What researchers measure

Primary outcomes

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

    Percentage change in UACR of cotadutide at different dose levels compared to placebo after 14 weeks. Efficacy endpoints for cotadutide vs. semaglutide are exploratory and are therefore excluded.

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

Secondary outcomes

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

    Percentage change in UACR of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks. Efficacy endpoints for cotadutide vs. semaglutide are exploratory and are therefore excluded.

    Time frame: Baseline to end of 26 weeks of dosing

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

    Percentage change in body weight of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks of dosing.

    Time frame: Baseline to end of 14 weeks of dosing

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

    Percentage change in body weight of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks of dosing

    Time frame: Baseline to end of 26 weeks of dosing

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

    Percentage change in HbA1c of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks of dosing

    Time frame: Baseline to end of 14 weeks of dosing

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

    Percentage change in HbA1c of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks of dosing

    Time frame: Baseline to end of 26 weeks of dosing

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

    Absolute change in fasting glucose of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks

    Time frame: Baseline to end of 14 weeks of dosing

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

    Absolute change in fasting glucose of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks

    Time frame: Baseline to end of 26 weeks of dosing

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

    Absolute change in 10-day average glucose of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks of dosing

    Time frame: Baseline to end of 14 weeks of dosing

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

    Absolute change in 10-day average glucose of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks of dosing

    Time frame: Baseline to end of 26 weeks of dosing

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

    Percentage change in 10-day percentage time spent in hyperglycaemia of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks

    Time frame: Baseline to 14 weeks of dosing

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

    Percentage change in 10-day percentage time spent in hyperglycaemia of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks

    Time frame: Baseline to 26 weeks of dosing

07

Results

Posted Jan 17, 2025

Participant flow

This study was conducted at 79 participating sites in Canada, Australia, New Zealand, Japan, Germany, Poland, Spain and United Kingdom. First subject enrolled 31st August 2020. Last subject last visit: 8th March 2022.

Participant flow — Overall Study
MilestoneCotadutide 100 ugCotadutide 300 ugCotadutide 600 ugPlacebo ugSemaglutide 1 mg
Started5249515145
Completed4945504843
Not completed34132
Withdrew: Adverse event00012
Withdrew: Death20000
Withdrew: Other:family emergency00010
Withdrew: Other:randomised by error01000
Withdrew: Other:subject hasa to fly to greece for a family emergency and will not be back till 4-5 months00010
Withdrew: Physician decision01000
Withdrew: Withdrawal by subject12100

Outcome measures

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

Percentage change in UACR of cotadutide at different dose levels compared to placebo after 14 weeks. Efficacy endpoints for cotadutide vs. semaglutide are exploratory and are therefore excluded.

Time frame:
Baseline to the end of 14 weeks of dosing
Reported as:
Geometric least squares mean · Percentage change
The Primary Endpoint Was Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks
Percentage changeCotadutide 100 ugCotadutide 300 µgCotadutide 600 µgPlacebo ug
The Primary Endpoint Was Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks-10.96 (-29.60 to 12.61)-40.47 (-53.00 to -24.60)-44.60 (-56.21 to -29.91)4.60 (-18.02 to 33.46)
SecondaryPercentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks

Percentage change in UACR of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks. Efficacy endpoints for cotadutide vs. semaglutide are exploratory and are therefore excluded.

Time frame:
Baseline to end of 26 weeks of dosing
Reported as:
Geometric least squares mean · Percentage change
Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks
Percentage changeCotadutide 100 ugCotadutide 300 µgCotadutide 600 µgPlacebo ug
Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks-17.85 (-45.47 to 23.78)-38.68 (-59.61 to -6.88)-57.87 (-73.33 to -33.45)11.79 (-27.85 to 73.22)
SecondaryPercent Change in Body Weight of Cotatudide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing

Percentage change in body weight of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks of dosing.

Time frame:
Baseline to end of 14 weeks of dosing
Reported as:
Least squares mean · Percentage change
Percent Change in Body Weight of Cotatudide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing
Percentage changeCotadutide 100 ugCotadutide 300 µgCotadutide 600 µgPlacebo ug
Percent Change in Body Weight of Cotatudide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing-2.84 ± 0.65-4.15 ± 0.68-5.40 ± 0.73-1.61 ± 0.66
SecondaryPercentage Change in Body Weight of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing

Percentage change in body weight of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks of dosing

Time frame:
Baseline to end of 26 weeks of dosing
Reported as:
Least squares mean · Percentage change
Percentage Change in Body Weight of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing
Percentage changeCotadutide 100 ugCotadutide 300 µgCotadutide 600 µgPlacebo ug
Percentage Change in Body Weight of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing-2.60 ± 0.89-5.45 ± 0.92-7.35 ± 0.99-2.23 ± 0.90
SecondaryPercent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 14 of Dosing

Percentage change in HbA1c of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks of dosing

Time frame:
Baseline to end of 14 weeks of dosing
Reported as:
Least squares mean · Percent change
Percent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 14 of Dosing
Percent changeCotadutide 100 µgCotadutide 300 µgCotadutide 600 µgPlacebo ug
Percent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 14 of Dosing-0.76 ± 0.12-0.82 ± 0.12-0.65 ± 0.12-0.08 ± 0.12
SecondaryPercent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 26 of Dosing

Percentage change in HbA1c of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks of dosing

Time frame:
Baseline to end of 26 weeks of dosing
Reported as:
Least squares mean · Percent change
Percent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 26 of Dosing
Percent changeCotadutide 100 µgCotadutide 300 µgCotadutide 600 µgPlacebo ug
Percent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 26 of Dosing-0.92 ± 0.11-0.92 ± 0.11-0.89 ± 0.11-0.25 ± 0.11
SecondaryChange in Fasting Glucose of Cotadutide at Different Dose Levels From Baseline Versus Placebo After 14 Weeks of Dosing

Absolute change in fasting glucose of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks

Time frame:
Baseline to end of 14 weeks of dosing
Reported as:
Least squares mean · mmol/L
Change in Fasting Glucose of Cotadutide at Different Dose Levels From Baseline Versus Placebo After 14 Weeks of Dosing
mmol/LCotadutide 100 ugCotadutide 300 µgCotadutide 600 µgPlacebo ug
Change in Fasting Glucose of Cotadutide at Different Dose Levels From Baseline Versus Placebo After 14 Weeks of Dosing-1.35 ± 0.37-1.57 ± 0.35-1.69 ± 0.40-0.54 ± 0.37
SecondaryChange in Fasting Glucose of Cotadutide at Different Dose Levels From Baseline Versus Placebo After 26 Weeks of Dosing

Absolute change in fasting glucose of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks

Time frame:
Baseline to end of 26 weeks of dosing
Reported as:
Least squares mean · mmol/L
Change in Fasting Glucose of Cotadutide at Different Dose Levels From Baseline Versus Placebo After 26 Weeks of Dosing
mmol/LCotadutide 100 ugCotadutide 300 µgCotadutide 600 µgPlacebo ug
Change in Fasting Glucose of Cotadutide at Different Dose Levels From Baseline Versus Placebo After 26 Weeks of Dosing-1.78 ± 0.36-1.76 ± 0.37-1.57 ± 0.39-0.72 ± 0.37
SecondaryChange in 10-day Average Glucose Levels of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing

Absolute change in 10-day average glucose of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks of dosing

Time frame:
Baseline to end of 14 weeks of dosing
Reported as:
Least squares mean · mmol/L
Change in 10-day Average Glucose Levels of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing
mmol/LCotadutide 100 ugCotadutide 300 µgCotadutide 600 µgPlacebo ug
Change in 10-day Average Glucose Levels of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing-1.556 ± 0.320-1.478 ± 0.337-1.269 ± 0.334-0.440 ± 0.311
SecondaryChange in 10-day Average Glucose Levels of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing

Absolute change in 10-day average glucose of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks of dosing

Time frame:
Baseline to end of 26 weeks of dosing
Reported as:
Least squares mean · mmol/L
Change in 10-day Average Glucose Levels of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing
mmol/LCotadutide 100 ugCotadutide 300 µgCotadutide 600 µgPlacebo ug
Change in 10-day Average Glucose Levels of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing-1.735 ± 0.307-1.446 ± 0.334-1.118 ± 0.321-0.273 ± 0.290
SecondaryChange in Percentage Time Spent in Hyperglycaemia Over 10 Days of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks of Dosing

Percentage change in 10-day percentage time spent in hyperglycaemia of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks

Time frame:
Baseline to 14 weeks of dosing
Reported as:
Least squares mean · Percent Change
Change in Percentage Time Spent in Hyperglycaemia Over 10 Days of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks of Dosing
Percent ChangeCotadutide 100 ugCotadutide 300 µgCotadutide 600 µgPlacebo ug
Change in Percentage Time Spent in Hyperglycaemia Over 10 Days of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks of Dosing-13.87 ± 3.35-15.79 ± 3.55-13.90 ± 3.52-4.09 ± 3.27
SecondaryChange in Percentage Time Spent in Hyperglycaemia Over 10 Days of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks of Dosing

Percentage change in 10-day percentage time spent in hyperglycaemia of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks

Time frame:
Baseline to 26 weeks of dosing
Reported as:
Least squares mean · Percent change
Change in Percentage Time Spent in Hyperglycaemia Over 10 Days of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks of Dosing
Percent changeCotadutide 100 ugCotadutide 300 µgCotadutide 600 µgPlacebo ug
Change in Percentage Time Spent in Hyperglycaemia Over 10 Days of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks of Dosing-18.06 ± 3.33-15.38 ± 3.76-11.91 ± 3.51-3.00 ± 3.17

Adverse events

Collected over Screening throughout the treatment period and including the follow-up period (28 days post last dose), an average of 37 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cotadutide 100 ug2/52 (3.8%)5/52 (9.6%)43/52 (82.7%)
Cotadutide 300 ug0/49 (0%)5/49 (10.2%)38/49 (77.6%)
Cotadutide 600 ug0/51 (0%)5/51 (9.8%)38/51 (74.5%)
Placebo ug0/51 (0%)5/51 (9.8%)38/51 (74.5%)
Semaglutide 1 mg0/45 (0%)5/45 (11.1%)39/45 (86.7%)
Most frequent serious events
Showing 10 of 26
Most frequent serious events
EventCotadutide 100 ugCotadutide 300 ugCotadutide 600 ugPlacebo ugSemaglutide 1 mg
Groin painMusculoskeletal and connective tissue disorders0/520/490/510/511/45
HypoxiaRespiratory, thoracic and mediastinal disorders0/520/490/510/511/45
PneumoniaInfections and infestations0/520/490/511/511/45
KetosisMetabolism and nutrition disorders0/520/490/510/511/45
VomitingGastrointestinal disorders0/520/490/510/511/45
Ischaemic strokeNervous system disorders0/521/490/510/510/45
Adjustment disorder with anxietyPsychiatric disorders0/521/490/510/510/45
Acute myocardial infarctionCardiac disorders1/521/490/510/510/45
Obstructive pancreatitisGastrointestinal disorders0/521/490/510/510/45
DiverticulitisInfections and infestations0/521/490/510/510/45
Most frequent other events
Showing 10 of 239
Most frequent other events
EventCotadutide 100 ugCotadutide 300 ugCotadutide 600 ugPlacebo ugSemaglutide 1 mg
HypoglycaemiaMetabolism and nutrition disorders13/5216/4913/5113/514/45
NauseaGastrointestinal disorders6/527/4914/515/5112/45
Decreased appetiteMetabolism and nutrition disorders0/523/495/511/518/45
DiarrhoeaGastrointestinal disorders5/527/496/514/517/45
VomitingGastrointestinal disorders2/523/497/512/517/45
ConstipationGastrointestinal disorders7/522/495/512/513/45
HypotensionVascular disorders0/521/493/510/515/45
DizzinessNervous system disorders1/524/492/511/511/45
DyspepsiaGastrointestinal disorders1/524/490/510/510/45
Back painMusculoskeletal and connective tissue disorders2/522/493/514/512/45

Baseline characteristics

The numbers above include all participants randomised in the different treatment arms.

Age, Continuous
Age, Continuous(Years)Cotadutide 100 ugCotadutide 300 ugCotadutide 600 ugPlacebo ugSemaglutide 1 mgTotal
Mean67.2 ± 7.365.7 ± 8.866.1 ± 7.469.5 ± 7.367.0 ± 7.867.1 ± 7.8
Sex: Female, Male
Sex: Female, Male(Participants)Cotadutide 100 ugCotadutide 300 ugCotadutide 600 ugPlacebo ugSemaglutide 1 mgTotal
Female9310131247
Male4346413833201
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cotadutide 100 ugCotadutide 300 ugCotadutide 600 ugPlacebo ugSemaglutide 1 mgTotal
AMERICAN INDIAN OR ALASKA NATIVE000000
ASIAN10101310245
BLACK OR AFRICAN AMERICAN200125
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER201104
OTHER031004
WHITE3836363941190
08

Study locations

83 sites
  • Research Site
    Box Hill, 3128, Australia
  • Research Site
    Elizabeth Vale, 5112, Australia
  • Research Site
    Fitzroy, 3065, Australia
  • Research Site
    Heidelberg, 3084, Australia
  • Research Site
    Melbourne, 3004, Australia
  • Research Site
    Merewether, 2291, Australia
  • Research Site
    Oaklands Park, 5046, Australia
  • Research Site
    Wollongong, 2500, Australia
  • Research Site
    Woolloongabba, 4102, Australia
  • Research Site
    Vancouver, British Columbia V5Y 3W2, Canada
  • Research Site
    Barrie, Ontario L4N 7L3, Canada
  • Research Site
    Brampton, Ontario L6S 0C6, Canada
  • Research Site
    Concord, Ontario L4K 4M2, Canada
  • Research Site
    Etobicoke, Ontario M9R 4E1, Canada
  • Research Site
    Oakville, Ontario L6M 1M1, Canada
  • Research Site
    Oshawa, Ontario L1G 2B9, Canada
  • Research Site
    Ottawa, Ontario K2J 0V2, Canada
  • Research Site
    Toronto, Ontario M4G 3E8, Canada
  • Research Site
    Toronto, Ontario M5G 2C4, Canada
  • Research Site
    Waterloo, Ontario N2T 0C1, Canada
  • Research Site
    Laval, Quebec H7T 2P5, Canada
  • Research Site
    Montreal, Quebec H4A 2C6, Canada
  • Research Site
    Berlin, 10409, Germany
  • Research Site
    Berlin, 10437, Germany
  • Research Site
    Berlin, 10789, Germany
  • Research Site
    Dortmund, 44137, Germany
  • Research Site
    Dusseldorf, 40210, Germany
  • Research Site
    Essen, 45359, Germany
  • Research Site
    Kassel, 34121, Germany
  • Research Site
    Ludwigshafen, 67059, Germany
  • Research Site
    Magdeburg, 39120, Germany
  • Research Site
    Mainz, 55116, Germany
  • Research Site
    München, 81241, Germany
  • Research Site
    Münster, 48145, Germany
  • Research Site
    Münster, 48153, Germany
  • Research Site
    Riesa, 01587, Germany
  • Research Site
    Sankt Ingbert, 66386, Germany
  • Research Site
    Arakawa-ku, 116-0012, Japan
  • Research Site
    Chitose-shi, 066-0032, Japan
  • Research Site
    Fujisawa-shi, 251-0041, Japan
  • Research Site
    Kamakura-shi, 247-8533, Japan
  • Research Site
    Obihiro-shi, 080-0848, Japan
  • Research Site
    Sapporo-shi, 060-0062, Japan
  • Research Site
    Shinjyuku-ku, 160-0022, Japan
  • Research Site
    Auckland, 2025, New Zealand
  • Research Site
    Auckland, ?0620, New Zealand
  • Research Site
    Christchurch, 8011, New Zealand
  • Research Site
    Grafton, 1010, New Zealand
  • Research Site
    Havelock North, 4130, New Zealand
  • Research Site
    New Plymouth, 4310, New Zealand
  • Research Site
    Tauranga, 3110, New Zealand
  • Research Site
    Wellington, 6021, New Zealand
  • Research Site
    Białystok, 15-435, Poland
  • Research Site
    Grodzisk Mazowiecki, 05-825, Poland
  • Research Site
    Katowice, 40-081, Poland
  • Research Site
    Krakow, 30-033, Poland
  • Research Site
    Krakow, 31-261, Poland
  • Research Site
    Kraków, 31-530, Poland
  • Research Site
    Lublin, 20064, Poland
  • Research Site
    Poznań, 61-655, Poland
  • Research Site
    Skierniewice, 96-100, Poland
  • Research Site
    Warszawa, 00-660, Poland
  • Research Site
    Warszawa, 01-518, Poland
  • Research Site
    Warszawa, 02-507, Poland
  • Research Site
    Wierzchosławice, 33-122, Poland
  • Research Site
    Barcelona, 08036, Spain
  • Research Site
    Cordoba, 14004, Spain
  • Research Site
    L'Hospitalet de Llobregat, 08907, Spain
  • Research Site
    La Coruna, 15006, Spain
  • Research Site
    Lérida, 25198, Spain
  • Research Site
    Madrid, 28006, Spain
  • Research Site
    Majadahonda, 28222, Spain
  • Research Site
    Malaga, 29010, Spain
  • Research Site
    Palma de Mallorca, 07010, Spain
  • Research Site
    Palma, 07198, Spain
  • Research Site
    Pozuelo de Alarcón, 28223, Spain
  • Research Site
    Sevilla, 41003, Spain
  • Research Site
    Sevilla, 41009, Spain
  • Research Site
    Valencia, 46009, Spain
  • Research Site
    Vitoria, 01009, Spain
  • Research Site
    Dundee, DD1 9SY, United Kingdom
  • Research Site
    Liverpool, L9 7AL, United Kingdom
  • Research Site
    London, SE5 9RS, United Kingdom
09

References and documents

Publications

  • Selvarajah V, Robertson D, Hansen L, Jermutus L, Smith K, Coggi A, Sanchez J, Chang YT, Yu H, Parkinson J, Khan A, Chung HS, Hess S, Dumas R, Duck T, Jolly S, Elliott TG, Baker J, Lecube A, Derwahl KM, Scott R, Morales C, Peters C, Goldenberg R, Parker VER, Heerspink HJL; study investigators. 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 Int. 2024 Dec;106(6):1170-1180. doi: 10.1016/j.kint.2024.08.023. Epub 2024 Aug 31. PubMed 39218393 ↗

Study documents

  • Study protocol · Jan 4, 2021
  • Statistical analysis plan · Mar 28, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04515849
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 17, 2020
Start date
Aug 31, 2020
Primary completion
Mar 8, 2022
Completion
Mar 8, 2022
Results posted
Jan 17, 2025
Last update
Jan 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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