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Completed

NCT Number: NCT05364931

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

The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.

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Key information

Conditions

Non-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis Digestive System Diseases Fatty Liver Fibrosis Liver Cirrhosis Liver Diseases Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, CABA, Argentina

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About this study

A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of cotadutide at 300 and 600 μg in participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of informed consent
  • Males and female participants ≥ 18 to ≤ 75 years of age (inclusive) at the time of signing the informed consent.
  • 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:
  • NAS (Non-alcoholic Fatty Liver Disease Activity Score) ≥ 4 with a score of ≥ 1 for each component: steatosis, lobular inflammation, and ballooning
  • Presence of fibrosis stage F2 or F3
  • 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

  • Chronic liver disease of other etiologies.
  • 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).
  • 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
  • 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.
  • 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.
  • Severe allergy/hypersensitivity to any of the proposed study treatments or excipients
  • 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
  • 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.

Treatment and study plan

Cotadutide

Drug

Cotadutide administered subcutaneously once daily

Placebo

Drug

Placebo administered subcutaneously once daily

Primary outcomes

  1. 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.

    To assess safety and tolerability of Cotadutide. Occurrence of AEs and serious AEs, including AEs leading to dose reduction, and AEs of special interest.

  2. 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.

    To assess safety and tolerability of Cotadutide.

  3. 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.

    To assess safety and tolerability of Cotadutide.

  4. 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.

    To assess safety and tolerability of Cotadutide.

  5. 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.

    To assess the immunogenicity of Cotadutide

  6. 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).

    To assess the immunogenicity of cotadutide. Titers represent a dilution and are therefore unitless. Summary statistics are based on the maximum observed titer for each ADA positive subject within the time frame.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: PROXYMO-ADV

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 6, 2022
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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