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Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist
Cotadutide for Non-alcoholic Steatohepatitis with Fibrosis (PROXYMO-ADV Trial)
Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 specific histological criteria: NAS ≥ 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.
Males and female participants aged ≥ 18 to ≤ 75 years at the time of signing the informed consent
Must not have
Severely uncontrolled hypertension
Chronic liver disease of other etiologies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose on day 1 until the follow-up period, 28 days post last dose
Summary
This trial is testing cotadutide, a medication aimed at reducing liver inflammation and scarring, in patients with non-cirrhotic NASH with fibrosis. The study will evaluate the safety and effectiveness of two different doses of the medication. Cenicriviroc (CVC) is another drug that has shown promise in treating NASH and liver fibrosis by inhibiting macrophage accumulation and improving liver fibrosis.
Who is the study for?
Adults aged 18-75 with non-cirrhotic NASH (Non-alcoholic Steatohepatitis) and fibrosis stage F2 or F3 can join this trial. They must have a confirmed diagnosis, not be pregnant or breastfeeding, and use birth control. People with recent cancer, severe allergies to study drugs, bleeding disorders preventing liver biopsy, uncontrolled high blood pressure, certain infections like HIV or hepatitis B/C, history of cirrhosis or significant heart disease are excluded.
What is being tested?
The trial is testing Cotadutide's safety and effectiveness against a placebo in treating NASH with fibrosis. Participants will receive either the drug Cotadutide by injection or a placebo without knowing which one they're getting to compare results fairly.
What are the potential side effects?
Possible side effects of Cotadutide may include reactions at the injection site such as redness or pain, gastrointestinal issues like nausea and vomiting, potential liver-related problems due to its target area of treatment for NASH with fibrosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My high blood pressure is not under control.
Select...
I have a long-term liver condition not caused by alcohol.
Select...
I have a history of severe liver disease, including signs of increased blood pressure in the liver.
Select...
I cannot safely undergo a liver biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose on day 1 until the follow-up period, 28 days post last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose on day 1 until the follow-up period, 28 days post last dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Treatment-induced Anti-Drug Antibody (ADA) participants
Number of participants with abnormal laboratory assessments
Number of participants with abnormal vital signs.
+3 moreSecondary study objectives
Part A: Absolute change from baseline in body weight
Part A: Change from baseline in HbA1c in participants with T2DM
Part A: Percent change from baseline in triglycerides
+11 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Cotadutide 600μgExperimental Treatment1 Intervention
Group II: Cotadutide 300μgExperimental Treatment1 Intervention
Group III: Placebo 600μgPlacebo Group1 Intervention
Group IV: Placebo 300μgPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cotadutide
Not yet FDA approved
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include GLP-1 receptor agonists and dual GLP-1 and glucagon receptor agonists like cotadutide. GLP-1 receptor agonists improve glycemic control, promote weight loss, and reduce liver fat by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying.
Dual GLP-1 and glucagon receptor agonists add the benefit of increased energy expenditure and further reduction of liver fat by activating glucagon receptors. These mechanisms are crucial for NAFLD patients as they target both metabolic dysfunction and hepatic steatosis, addressing the core issues of the disease.
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,368 Previous Clinical Trials
288,736,705 Total Patients Enrolled
15 Trials studying Non-alcoholic Fatty Liver Disease
3,430 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver has moderate to severe scarring.My high blood pressure is not under control.I have a long-term liver condition not caused by alcohol.I am using birth control and am not pregnant or breastfeeding.I haven't had cancer in the last 5 years, except for certain skin cancers or localized cancers that were treated.My liver condition was confirmed as NASH by a biopsy within the last 6 months.I am between 18 and 75 years old.I have a history of severe liver disease, including signs of increased blood pressure in the liver.I cannot safely undergo a liver biopsy.I haven't had a heart or stroke issue in the last 3 months.I am between 18 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Cotadutide 300μg
- Group 2: Placebo 600μg
- Group 3: Cotadutide 600μg
- Group 4: Placebo 300μg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT05364931 — Phase 2
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