Cotadutide 300μg for Fatty Liver

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Research Site, Petach-Tikva, Israel
Fatty Liver+3 More
Cotadutide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions

  • Fatty Liver
  • Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Fatty Liver

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Week 84

Week 48
Proportion of participants with improvement of liver fibrosis by at least one stage without worsening of NASH
Proportion of participants with resolution of NASH without worsening of liver fibrosis
Week 84
Absolute change from baseline in body weight
Change from baseline in HbA1c in participants with T2DM
Percent change from baseline in triglycerides
Proportion of participants with both resolution of NASH and improvement in fibrosis by at least one stage
Proportion of participants with • resolution of NASH without worsening of liver fibrosis • improvement of liver fibrosis by at least one stage without worsening of NASH

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Fatty Liver

Trial Design

4 Treatment Groups

Cotadutide 300μg
1 of 4
Cotadutide 600μg
1 of 4
Placebo 600μg
1 of 4
Placebo 300μg
1 of 4
Experimental Treatment
Non-Treatment Group

1860 Total Participants · 4 Treatment Groups

Primary Treatment: Cotadutide 300μg · Has Placebo Group · Phase 2 & 3

Cotadutide 300μg
Drug
Experimental Group · 1 Intervention: Cotadutide · Intervention Types: Drug
Cotadutide 600μg
Drug
Experimental Group · 1 Intervention: Cotadutide · Intervention Types: Drug
Placebo 600μg
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo 300μg
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cotadutide
2020
Completed Phase 1
~20

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 84
Closest Location: Research Site · Gilroy, CA
1900First Recorded Clinical Trial
9 TrialsResearching Fatty Liver
2948 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have non-alcoholic fatty liver disease (NAFLD) with a score of ≥ 4 for each component.
You are 18 to 75 years of age.
You are 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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.