CompletedPhase 2

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

United States, Argentina, Australia54 participantsStarted 2022-07-14

Plain-language summary

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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Adverse Events (AEs).

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

Number of Participants With Abnormal Vital Signs.

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

Number of Participants With Abnormal Laboratory Assessments

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

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

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

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

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

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

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

Trial details

NCT IDNCT05364931

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-19

Results submitted2025-04-16

View on ClinicalTrials.gov More Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Adverse Events (AEs).

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

Number of Participants With Abnormal Vital Signs.

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

Number of Participants With Abnormal Laboratory Assessments

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

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

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

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

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

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

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