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. - PROXYMO-ADV

Study identifier:D5671C00006

ClinicalTrials.gov identifier:NCT05364931

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase IIb/III Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Cotadutide in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis with Fibrosis

Medical condition

Non-cirrhotic Non-alcoholic Steatohepatitis with Fibrosis

Phase

Phase 2/3

Healthy volunteers

Study drug

Cotadutide, Placebo

Sex

All

Estimated Enrollment

1860

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 14 Jul 2022

Estimated Primary Completion Date: 26 Mar 2026

Estimated Study Completion Date: 26 Mar 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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

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Arms	Assigned Interventions
Experimental: Cotadutide 300μg	Drug: Cotadutide Cotadutide administered subcutaneously once daily
Placebo Comparator: Placebo 300μg	Drug: Placebo Placebo administered subcutaneously once daily
Experimental: Cotadutide 600μg	Drug: Cotadutide Cotadutide administered subcutaneously once daily
Placebo Comparator: Placebo 600μg	Drug: Placebo Placebo administered subcutaneously once daily

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]