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Section 1 of 6Overview
Overview
Cotadutide (development codes MEDI0382 / MEDI-0382) is a dual GLP-1 receptor / glucagon receptor (GCGR) co-agonist developed by AstraZeneca (with MedImmune as collaborator on early studies). Clinical protocols used once-daily subcutaneous dosing. PubChem CID 134694273 records CAS 1686108-82-6, formula C₁₆₇H₂₅₂N₄₂O₅₅, and MW about 3728 Da.
Highest completed clinical phase was phase 2. AstraZeneca discontinued the programme in early 2023. ClinicalTrials.gov whyStopped language on terminated follow-on studies cites strategic pipeline considerations and states the stop was not due to any newly observed safety signals. No phase 3 efficacy programme was completed, and no FDA or EMA approval exists.
Not the same medicine as active GLP-1/glucagon duals
Mazdutide and survodutide are other dual GLP-1/glucagon agonists with separate sponsors and still-active or differently staged pipelines. Cotadutide is a discontinued historical candidate, not “the next mazdutide.” There is no head-to-head trial linking these molecules.
Section 2 of 6Clinical development (selected)
Clinical development (selected)
| NCT | Phase | Status (dossier cut) | Role |
|---|---|---|---|
| NCT03235050 (opens in a new tab) | 2b | Completed (n=834) | T2D + overweight/obesity vs placebo + open-label liraglutide; PMID 34016612 (opens in a new tab) |
| NCT04515849 (opens in a new tab) | 2b | Completed (~248) | CKD + T2D + albuminuria vs placebo + open-label semaglutide; PMID 39218393 (opens in a new tab) |
| NCT05364931 (opens in a new tab) | 2 | Completed (n=54) | PROXYMO-ADV non-cirrhotic NASH F2/F3 — Part B (phase 3) not run after discontinue |
| NCT05517226 (opens in a new tab) | 1 | Terminated | Hepatic impairment PK — stopped with programme discontinuation |
| NCT05668936 (opens in a new tab) | 1 | Terminated | Thorough QTc — stopped with programme discontinuation |
Section 3 of 6Key human results (peer-reviewed / registry)
Key human results (peer-reviewed / registry)
Phase 2a — Lancet 2018 (PMID 29945727)
Ambery et al. reported early clinical MEDI0382 work in overweight/obese type 2 diabetes, including ascending-dose and phase 2a glucose-AUC and weight outcomes versus placebo. Treat as early peer-reviewed human data, not a registrational package.
Phase 2b metabolic / hepatic — Diabetes Care 2021 (PMID 34016612; NCT03235050)
Fifty-four-week randomised phase 2b (n=834): cotadutide 100 / 200 / 300 µg daily versus placebo versus open-label liraglutide 1.8 mg. HbA1c and weight endpoints were assessed at weeks 14 and 54; liver biomarkers improved at 300 µg versus placebo in the published comparison (not with liraglutide in the same contrast). Common adverse events included nausea (~35%) and vomiting (~17%), reported to decrease over time. Open-label liraglutide arms do not support labelled superiority claims.
Phase 2b diabetic kidney disease — PMID 39218393 (NCT04515849)
Randomised phase 2b in CKD with T2D and albuminuria. Reported UACR reductions on the order of ~44% (300 µg) and ~50% (600 µg) versus placebo at week 14, with persistence described to week 26 in abstract/synthesis framing. Keep numbers tied to the cited paper; this is phase 2 biomarker evidence, not an approved kidney indication.
PROXYMO-ADV NASH — NCT05364931 / EudraCT 2021-005484-53
Originally framed as a two-part phase IIb/III programme. After discontinuation, Part A continued for safety, with efficacy treated as exploratory; Part B (phase 3) was not conducted. The trial completed in 2024; EU results were posted in 2025. Do not claim NASH efficacy approval or a completed phase 3 NASH package from this truncated programme.
Section 4 of 6Claims vs evidence
Claims vs evidence
| Claim | Assessment |
|---|---|
| Dual GLP-1 / glucagon agonist; INN cotadutide = MEDI0382 | Supported (Lancet; Diabetes Care; PubChem; CT.gov) |
| Published phase 2 human data (T2D, DKD) | Supported (PMID 29945727, 34016612, 39218393) |
| Discontinued 2023 for strategic reasons (not a new safety signal) | Supported (CT.gov whyStopped) |
| Phase 3 completed / approved product | False |
| Superior overall to liraglutide or semaglutide | Weak / context-only — open-label comparators in phase 2b |
| Active research-vendor “cotadutide peptide” equals the clinical candidate | Reject framing — discontinued investigational drug, not a research-reagent monograph use-case |
| PROXYMO proves NASH phase 3 efficacy | Unsupported — exploratory/safety after discontinue; Part B never run |
Section 5 of 6Related pages
Related pages
- Mazdutide, Survodutide — other GLP-1/glucagon dual agonists (different molecules)
- Semaglutide, Liraglutide — GLP-1 receptor agonists used as open-label comparators in cotadutide phase 2b
- Exenatide — earlier GLP-1 lineage context
Section 6 of 6What this page intentionally omits
What this page intentionally omits
- Any self-use dose, titration schedule, or reconstitution protocol
- Active-pipeline marketing tone for a discontinued programme
- Equating vendor “research peptide” listings with the AstraZeneca clinical candidate