Cotadutide

Also known as: MEDI0382

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 12 of 64 publications on PubMed
Registered clinical trials 24 0 active
Adverse event reports 0 0 classified as serious
  • Cotadutide is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 64 publications mentioning it, including 12 randomized controlled trials and 11 animal-only studies.
  • ClinicalTrials.gov lists 24 registered studies testing it (0 active).
  • FDA’s adverse event system (FAERS) has no reports mentioning it.

Research topics

  • Diabetes Mellitus, Type 2 35
  • Glucagon-Like Peptide-1 Receptor Agonists 27
  • Hypoglycemic Agents 26
  • Glucagon-Like Peptide 1 25
  • Obesity 24
  • Receptors, Glucagon 24
  • Blood Glucose 13
  • Body Weight 10
  • Glucagon 10
  • Glucagon-Like Peptide-1 Receptor 10

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 64
  • Human (MeSH) 43
  • Animal only 11
  • Clinical trials 13
  • Randomized controlled trials 12
  • Systematic reviews & meta-analyses 8
  • Case reports 0
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
24
Active
0
With posted results
12

Conditions studied

  • Type 2 Diabetes Mellitus 8
  • Non-alcoholic Steatohepatitis 2
  • Type 2 Diabetes 2
  • Obesity 2
  • Renal Insufficiency 2
  • Healthy Volunteers 2
  • Hepatic Impairment 1
  • Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis 1
  • Type 2 Diabetes Mellitus (T2DM) 1
  • Chronic Kidney Disease 1
  • Diabetes 1
  • Chronic Kidney Diseases 1
Study Status Phase Start
A Thorough QTC Study to Assess the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants
NCT05668936 AstraZeneca
Terminated Phase 1 January 3, 2023
Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment
NCT05517226 AstraZeneca
Terminated Phase 1 September 6, 2022
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
NCT05364931 AstraZeneca Results posted
Completed Phase 2 July 14, 2022
A Randomised, Open-Label Study to Evaluate the Relative and Absolute Bioavailability of Cotadutide in Healthy Subjects
NCT05294458 AstraZeneca
Completed Phase 1 March 28, 2022
Chinese Multiple Dose Escalation (MDE) High Dose Study
NCT05437848 AstraZeneca
Completed Phase 1 February 25, 2022
A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus
NCT04515849 AstraZeneca Results posted
Completed Phase 2 August 31, 2020
Safety and Tolerability Study of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes Melitus
NCT04208620 AstraZeneca
Completed Phase 1 January 21, 2020
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
NCT04091373 MedImmune LLC
Completed Phase 1 September 27, 2019
A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.
NCT04019561 MedImmune LLC Results posted
Completed Phase 2 September 23, 2019
A Study to Evaluate the Safety and Tolerability of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus
NCT03745937 MedImmune LLC Results posted
Completed Phase 2 January 7, 2019
Show 14 more studies
Study Status Phase Start
A Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Participants With Type 2 Diabetes Mellitus
NCT03596177 MedImmune LLC Results posted
Completed Phase 2 September 26, 2018
A Study to Assess Safety, Tolerability, and Pharmacokinetics of MEDI0382 in Non-diabetic Obese Participants
NCT03625778 MedImmune LLC
Completed Phase 1 August 14, 2018
Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes
NCT03645421 AstraZeneca Results posted
Completed Phase 2 August 10, 2018
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
NCT03550378 MedImmune LLC Results posted
Completed Phase 2 June 29, 2018
A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
NCT03555994 MedImmune LLC Results posted
Completed Phase 2 May 31, 2018
Study of MEDI0382 in Combination With Dapagliflozin and Metformin in Overweight/Obese Participants With Type 2 Diabetes
NCT03444584 MedImmune LLC Results posted
Completed Phase 2 May 8, 2018
A Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Overweight/Obese Subjects of Japanese or Chinese Descent
NCT03385369 MedImmune LLC
Completed Phase 1 January 5, 2018
A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382
NCT03341013 MedImmune LLC
Completed Phase 1 November 30, 2017
Study to Compare Pharmacokinetics & Pharmacodynamics of Warfarin & Esmolol in the Absence & Presence of MEDI0382
NCT03347968 MedImmune LLC
Completed Phase 1 November 27, 2017
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects
NCT03235375 MedImmune LLC
Completed Phase 1 October 27, 2017
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
NCT03244800 MedImmune LLC Results posted
Completed Phase 2 September 4, 2017
A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes
NCT03235050 AstraZeneca Results posted
Completed Phase 2 August 2, 2017
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
NCT02548585 MedImmune LLC Results posted
Completed Phase 1, Phase 2 December 9, 2015
A Phase 1, Single Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers
NCT02394314 MedImmune LLC
Completed Phase 1 Feb 2015

All 24 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

No FAERS reports mention this peptide.

Source: FDA FAERS · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.