Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Cotadutide (MEDI0382): what the evidence says

Name: Cotadutide (MEDI0382)
Published: 2026-10-27

At a glance

What it is: a once-daily injected peptide that activates both GLP-1 and glucagon receptors, from AstraZeneca/MedImmune. ^R1 AstraZeneca dropped it in 2023 for portfolio reasons and moved to a weekly successor. ^{R2, R3}

What the evidence says: in a 54-week phase 2b (834 adults with obesity and type 2 diabetes), it cut HbA1c and weight vs placebo and improved liver markers. ^R4 In diabetic kidney disease, it lowered urine albumin by up to about 50%. ^R5 It improved liver fat in a small MASH study. ^R6

Biggest risks: stomach side effects (72% vs 40% with placebo in an early trial). ^R1

Rating


Human Human evidence	Moderate: phase 2a/2b trials, n = 51 to 834 ^{R1, R4, R5, R7}
Animal Animal / lab evidence	Animal MASH models (per sponsor protocol) ^R8
Regulatory	Never approved; discontinued ^R2 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page ^{R9, R10, R11} · not named by WADA ^R12
Established human dose	None

Evidence verdict: Weight and glucose in type 2 diabetes: Moderate (phase 2b) · Liver fat / MASH: Limited · Kidney: Limited (phase 2b, albuminuria only) · Status: Development stopped

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: all efficacy data are phase 2 surrogate outcomes (HbA1c, weight, liver fat, albuminuria). No outcome trials exist. The stop was not for safety. ^R3

What is it?

Related pages: Survodutide, Mazdutide, Pemvidutide, Efinopegdutide.

Does it work?

Human Phase 2a (n = 51): weight −3.84 kg vs −1.70 kg with placebo. ^R1
Human Phase 2b (n = 834): lower HbA1c and weight at weeks 14 and 54; weight loss at the middle dose similar to liraglutide. ^R4
Human Kidney phase 2b: urine albumin −44% to −50% vs placebo at 14 weeks. ^R5
Human MASH: improved liver fat and enzymes. ^R6

Is it safe?

Human Stomach effects and decreased appetite were more common than with placebo. ^R1 In the kidney trial, serious events were balanced. ^R5

Gray-market vials: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US: never approved; the phase 3 part of the MASH program was cancelled. ^R8
Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. ^{R9, R10, R11}
Sport: not named on WADA's 2026 Prohibited List. ^R12

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
Phase 2a 2018	51 adults, T2D + obesity	SC daily	Titrated per protocol	41 days	Weight −3.84 vs −1.70 kg	PMID 29945727
Phase 2b 2021	834 adults, T2D + obesity	SC daily	100, 200 or 300 µg	54 weeks	HbA1c and weight down	PMID 34016612
Kidney phase 2b 2024	Adults with T2D + CKD	SC daily	Up to 100, 300 or 600 µg	26 weeks	UACR down up to ~50%	PMID 39218393

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)

^R1 Ambery P, et al. Lancet. 2018. PMID 29945727
^R2 AstraZeneca, Q1 2023 results announcement (cotadutide daily formulation discontinued due to portfolio prioritisation). https://www.astrazeneca.com/content/dam/az/PDF/2023/q1/Q1-2023-results-announcement.pdf
^R3 ClinicalTrials.gov NCT05668936, cotadutide QTc study, terminated for strategic reasons (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT05668936
^R4 Nahra R, et al. Diabetes Care. 2021. PMID 34016612
^R5 Selvarajah V, et al. Kidney Int. 2024. PMID 39218393
^R6 Shankar SS, et al. Clin Gastroenterol Hepatol. 2024. PMID 38729399
^R7 Parker VER, et al. Diabetes Obes Metab. 2022. PMID 35403793
^R8 ClinicalTrials.gov NCT05364931, cotadutide phase 2/3 MASH study, phase 3 part cancelled (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT05364931
^R9 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R10 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R11 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R12 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Cotadutide (MEDI0382). This is an investigational drug. Outside a registered clinical trial, any product sold under this name is unregulated. Development has stopped, so no legitimate product exists. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).