Current partner codePEPTIDESDE
NCT05364931·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

54

Locations

115

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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

Full detailed description

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.

Interventions

Treatment arms and agents.

DRUG

Cotadutide

Cotadutide administered subcutaneously once daily

DRUG

Placebo

Placebo administered subcutaneously once daily

Timeline

From registration to results.

  1. First posted

    May 6, 2022

  2. Study start

    Jul 14, 2022

  3. Primary completion

    Apr 19, 2024

  4. Study completion

    Apr 19, 2024

  5. Results posted

    Sep 3, 2025

  6. Registry updated

    Sep 3, 2025

Outcomes

What the study measures.

Primary outcomes

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.

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.

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.

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.

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

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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

115 registered sites.

Argentina · Australia · Austria · Canada · France · Germany · Greece · Israel · Italy · Japan · Malaysia · New Zealand · South Africa · South Korea · Spain · Taiwan · Thailand · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

Research Site

Tucson, Arizona, United States

Research Site

Canoga Park, California, United States

Research Site

Gilroy, California, United States

Research Site

Sacramento, California, United States

Research Site

Englewood, Colorado, United States

Research Site

Bradenton, Florida, United States

Research Site

Homestead, Florida, United States

Research Site

Jacksonville, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Winter Park, Florida, United States

Research Site

Munster, Indiana, United States

Research Site

Houma, Louisiana, United States

Research Site

Marrero, Louisiana, United States

Research Site

Marrero, Louisiana, United States

Research Site

Shreveport, Louisiana, United States

Research Site

Ann Arbor, Michigan, United States

Research Site

Las Vegas, Nevada, United States

Research Site

Las Vegas, Nevada, United States

Research Site

Lawrence, New Jersey, United States

Research Site

Warren Township, New Jersey, United States

Research Site

Morehead City, North Carolina, United States

Research Site

Chattanooga, Tennessee, United States

Research Site

Arlington, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Cotadutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.