18 completed, 2 terminated. 12 Phase 2, 9 Phase 1.
By phase and status
Follow cotadutide: new trials by email Literature Review of cotadutide trials Research Report on cotadutide
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
A Thorough QTC Study to Assess the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants Cotadutide, Cotadutide-placebo, Moxifloxacin - Non-alcoholic Steatohepatitis | Phase 1 | Terminated | 31 | 2023-01-03 | 2023-04-05 |
Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment Cotadutide - Hepatic Impairment | Phase 1 | Terminated | 24 | 2022-09-06 | 2023-03-21 |
A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis Cotadutide, Placebo - Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis | Phase 2 | Completed | 54 | 2022-07-14 | 2025-09-03 |
A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus Cotadutide 100 micrograms, Cotadutide 300 micrograms, Cotadutide 600 micrograms - Type 2 Diabetes Mellitus, Chronic Kidney Diseases | Phase 2 | Completed | 248 | 2020-08-31 | 2025-01-17 |
Safety and Tolerability Study of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes Melitus Placebo, Cotadutide - Type 2 Diabetes | Phase 1 | Completed | 16 | 2020-01-21 | 2020-07-31 |
A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH. MEDI0382 high dose, Placebo for MEDI0382 high dose, MEDI0382 low dose - Non-alcoholic Fatty Liver Disease (NAFLD), Non-alcoholic Steatohepatitis (NASH) | Phase 2 | Completed | 74 | 2019-09-23 | 2023-01-17 |
A Study to Evaluate the Safety and Tolerability of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus MEDI0382, Placebo - Type 2 Diabetes Mellitus | Phase 2 | Completed | 20 | 2019-01-07 | 2020-06-05 |
A Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Participants With Type 2 Diabetes Mellitus MEDI0382, Placebo - Diabetes Mellitus, Type II, Obesity | Phase 2 | Completed | 28 | 2018-09-26 | 2023-01-19 |
A Study to Assess Safety, Tolerability, and Pharmacokinetics of MEDI0382 in Non-diabetic Obese Participants MEDI0382, Placebo - Obesity | Phase 1 | Completed | 51 | 2018-08-14 | 2021-08-23 |
Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes MEDI0382 100 μg, MEDI0382 200 μg, MEDI0382 300 μg - Type 2 Diabetes | Phase 2 | Completed | 61 | 2018-08-10 | 2019-12-23 |
A Study to Look at the Effect MEDI0382 Has on Blood Sugar in People With Type 2 Diabetes and Kidney Problems and Also to Check That MEDI0382 is Well Tolerated MEDI0382, Placebo - Type II Diabetes Mellitus, Renal Insufficiency | Phase 2 | Completed | 41 | 2018-06-29 | 2020-04-13 |
A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus. MEDI0382, Placebo, Liraglutide - Type 2 Diabetes Mellitus | Phase 2 | Completed | 51 | 2018-05-31 | 2024-11-12 |
Study of MEDI0382 in Combination With Dapagliflozin and Metformin in Overweight/Obese Participants With Type 2 Diabetes MEDI0382, Placebo, Dapaglifozin - Type 2 Diabetes Mellitus | Phase 2 | Completed | 49 | 2018-05-08 | 2020-01-13 |
A Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Overweight/Obese Subjects of Japanese or Chinese Descent MEDI0382, Placebo - Safety, Healthy Subjects | Phase 1 | Completed | 32 | 2018-01-05 | 2019-04-16 |
Study to Compare Pharmacokinetics & Pharmacodynamics of Warfarin & Esmolol in the Absence & Presence of MEDI0382 MEDI0382, Warfarin, Esmolol - Healthy Volunteers | Phase 1 | Completed | 22 | 2017-11-27 | 2018-04-25 |
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects MEDI0382 - Renal Insufficiency | Phase 1 | Completed | 37 | 2017-10-27 | 2018-05-01 |
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus. MEDI0382, Placebo - Type 2 Diabetes Mellitus | Phase 2 | Completed | 65 | 2017-09-04 | 2019-11-19 |
A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes MEDI0382 low dose, MEDI0382 mid dose, MEDI0382 high dose - Diabetes Mellitus, Type 2 | Phase 2 | Completed | 834 | 2017-08-02 | 2020-08-17 |
A Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus MEDI0382, Placebo - Type 2 Diabetes Mellitus | Phase 1 / Phase 2 | Completed | 113 | 2015-12-09 | 2019-04-05 |
A Phase 1, Single Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers MEDI0382, Placebo - Healthy Volunteers | Phase 1 | Completed | 362 | 2015-02-01 | 2015-09-09 |
Conditions studied
Diabetes Mellitus, Type 2 (12) · Diabetes Mellitus (5) · Obesity (4) · Non-alcoholic Fatty Liver Disease (3) · Overweight (3) · Renal Insufficiency (2) · Diabetic Nephropathies (1) · Liver Cirrhosis (1) · Renal Insufficiency, Chronic (1)
Sponsors
MedImmune LLC (13) · AstraZeneca (7)
Countries
Germany (11) · United States (7) · United Kingdom (6) · Japan (4) · Canada (3) · New Zealand (3) · Australia (2) · Spain (2) · Argentina (1) · Austria (1) · Bulgaria (1) · Czechia (1) · France (1) · Greece (1) · Hungary (1)
Top investigators
Tim Heise, MD (2) · Armando Flor (1) · Michael Stumvoll (1) · Peter J Winkle, MD, FACP, FACG, CPI (1) · Stephen Bain, MD (1)
Results publications
PMID 39963952, PMID 29945727, PMID 31608926, PMID 34016612, PMID 35403793, PMID 37140727, PMID 38066113, PMID 38403793, PMID 38562018, PMID 38729399, PMID 39218393, PMID 40344607, PMID 40665896
NIH funding
2017 (2), 2018 (1)