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CompletedPhase 2Results posted

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

A Phase II Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Cotadutide in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

Lead sponsor

AstraZeneca

Asset

Cotadutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

115

Recruiting sites

Enrollment

54

actual

Study population

MASH / NAFLD / liver fibrosis

Key I/E criterion

Primary endpoints

Adverse Events (AEs)Abnormal Vital SignsAbnormal Laboratory Assessments

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05364931
Org study IDD5671C00006
Secondary ID2021-005484-53

Timeline

Milestones

Study first posted2022-05-06actual
Study start2022-07-14actual
Primary completion2024-04-19actual
Study completion2024-04-19actual
Last update posted2025-09-03actual
Results first posted2025-09-03actual

Assets

Investigational agents

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosis

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Provision of informed consent

2. Males and female participants ≥ 18 to ≤ 75 years of age (inclusive) at the time of signing the informed consent.

3. Histologically confirmed non-alcoholic steatohepatitis (NASH) per NASH Clinical Research Network (CRN) criteria as diagnosed by histology from a liver biopsy performed ≤ 180 days from randomization and fulfilling all of the following histological criteria:

1. NAS (Non-alcoholic Fatty Liver Disease Activity Score) ≥ 4 with a score of ≥ 1 for each component: steatosis, lobular inflammation, and ballooning

2. Presence of fibrosis stage F2 or F3

4. Women of childbearing potential, non-pregnant and nonbreastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study intervention.

Exclusion criteria

1. Chronic liver disease of other etiologies.

2. History of cirrhosis and/or hepatic decompensation, including evidence of portal hypertension (e.g. low platelet count, splenomegaly, ascites, history of hepatic encephalopathy, esophageal varices, or variceal bleeding).

3. Clinically significant cardiovascular or cerebrovascular disease within 90 days prior to screening, including but not limited to, myocardial infarction, acute coronary syndrome, unstable angina pectoris, transient ischemic attack, or stroke, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 90 days or who are due to undergo these procedures at the time of screening

4. History of malignant neoplasms within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or any in situ carcinoma.

5. Participation in another clinical study with an investigational product administered within the last 30 days or 5 half-lives of the therapy (whichever is longer) at the time of screening or the time of the historical biopsy or concurrent participation in another interventional study of any kind or prior randomization in this study.

6. Severe allergy/hypersensitivity to any of the proposed study treatments or excipients

7. Contraindication to liver biopsy (eg, bleeding diathesis, such as hemophilia, suspected hemangioma, or suspected echinococcal infection) or inability to safely obtain a liver biopsy as determined by the investigator

8. Severely uncontrolled hypertension defined as SBP ≥ 180 mmHg or DBP ≥ 110 mmHg on the average of 2 seated BP measurements after being at rest for at least 10 minutes at screening or randomization 9 Any positive results for human immunodeficiency virus infection, positive results for hepatitis B surface antigen or hepatitis C antibody test along with a positive HCV RNA test.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

12 endpoints
Primary/registry result

Number of Participants With Adverse Events (AEs).

Time frame:First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Cotadutide 300 ug16
Cotadutide 600 ug16
Placebo13
Primary/registry result

Number of Participants With Abnormal Vital Signs.

Time frame:First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Cotadutide 300 ug13
Cotadutide 600 ug14
Placebo17
Primary/registry result

Number of Participants With Abnormal Laboratory Assessments

Time frame:First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Cotadutide 300 ug16
Cotadutide 600 ug17
Placebo19
Primary/registry result

Number of Participants With Treatment Emergent Abnormality in 12-lead Electrocardiogram (ECG).

Time frame:First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Cotadutide 300 ug4
Cotadutide 600 ug2
Placebo6
Primary/registry result

Number of Treatment-induced Anti-Drug Antibody (ADA) Participants

Time frame:First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Cotadutide 300 ug7
Cotadutide 600 ug11
Placebo0
Primary/registry result

Titer of Treatment-induced Anti-Drug Antibody (ADA)

Time frame:From first dose on Day 1 until the follow-up period, 28 days post last dose (from randomization up to approximately 52 weeks).

descriptive

Posted result

GroupValue (median), titer95% CI
Cotadutide 300 ug24015 – 7680
Cotadutide 600 ug6015 – 240
Primary/protocol endpoint

Number of Participants With Adverse Events (AEs).

Time frame:First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Number of Participants With Abnormal Vital Signs.

Time frame:First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

descriptive

Primary/protocol endpoint

Number of Participants With Abnormal Laboratory Assessments

Time frame:First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

descriptive

Primary/protocol endpoint

Number of Participants With Treatment Emergent Abnormality in 12-lead Electrocardiogram (ECG).

Time frame:First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

event count, event

Primary/protocol endpoint

Number of Treatment-induced Anti-Drug Antibody (ADA) Participants

Time frame:First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

Immunogenicity (ADA)

threshold achievement, event

Primary/protocol endpoint

Titer of Treatment-induced Anti-Drug Antibody (ADA)

Time frame:From first dose on Day 1 until the follow-up period, 28 days post last dose (from randomization up to approximately 52 weeks).

Immunogenicity (ADA)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.