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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose on day 1 until the follow-up period, 28 days post last dose
Awards & highlights
PROXYMO-ADV Trial Summary
This trial will test if cotadutide is safe and effective in treating non-cirrhotic NASH with 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.Check my eligibility
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.See study design
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.
PROXYMO-ADV Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
PROXYMO-ADV Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 morePROXYMO-ADV Trial 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
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,732 Total Patients Enrolled
15 Trials studying Non-alcoholic Fatty Liver Disease
3,390 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research being conducted extensively throughout the nation?
"There are 64 different centres running this trial, which makes it widely accessible. The locations of the sites can be found on the website and include cities such as Red Oak, Chicago and Rialto. Patients should try to select a location that is close to them in order to reduce travel time and costs."
Answered by AI
Are we able to enroll octogenarians in this research project?
"The age range for patients that are eligible to enroll in this study is 18-75 years old."
Answered by AI
Who else is applying?
What state do they live in?
California
Utah
Other
Virginia
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Hoping this will help address this condition. I need the money, I also wold like to help others with fatty livers.
PatientReceived 1 prior treatment
Better healthy liver possibly,. Money. Help with good data about nafld.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Research Site: < 24 hours
Average response time
- < 1 Day
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