Semaglutide for Nonalcoholic Steatohepatitis

Phase-Based Progress Estimates

Effectiveness

Safety

Nonalcoholic Steatohepatitis+2 More

Semaglutide - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial is studying a medication called semaglutide in patients with NASH. Semaglutide is a well-known medication used to treat type 2 diabetes, and participants will either receive semaglutide or a dummy medication, with no way of knowing which they're getting. The study will last for 5 years, during which participants will have to inject themselves weekly and will have 21 clinic visits and 9 phone calls with clinical staff. Some of the clinic visits may last more than one day.

Eligible Conditions

Nonalcoholic Steatohepatitis
Steatohepatitis

Treatment Effectiveness

Effectiveness Progress

2 of 3

This is further along than 85% of similar trials

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CAM2029

Cotadutide

Study Objectives

3 Primary · 27 Secondary · Reporting Duration: From randomisation (week 0) to week 240

Week 240

Change in body weight

Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No)

Part 2: Time to first liver-related clinical event (composite endpoint)

Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)

Time to first MACE(Major Adverse Cardiovascular event ) (composite endpoint)

Time to first major cardio-hepatic event (composite endpoint)

Week 72

Change in ALT (alanine aminotransferase)

Change in AST (aspartate aminotransferase)

Change in ELF (Enhanced Liver Fibrosis) score

Change in HDL (High density lipoprotein ) cholesterol

Change in HbA1c (glycated haemoglobin)

Change in LDL (low-density lipoprotein) cholesterol

Change in SF-36 (Short Form 36) Bodily Pain

Change in free fatty acids

Change in histology-assessed liver collagen proportionate area

Change in inflammation assessed by hsCRP (High Sensitive C-Reactive Protein)

Change in liver stiffness assessed by FibroScan®

Change in triglyceride

Changes in NASH-CHECK Pain

Changes in SF-36 (Short Form 36 v2.0 acute ) Physical Component Summary

Changes in SF-36 Mental Component Summary

Improvement in histology-assessed ballooning (Yes/No)

Improvement in histology-assessed inflammation (Yes/No)

Improvement in histology-assessed steatosis (Yes/No)

Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No)

Part 1: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No)

Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)

Progression of liver fibrosis (Yes/No)

Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)

Worsening in steatohepatitis (Yes/No)

Trial Safety

Safety Progress

3 of 3

This is further along than 85% of similar trials

Similar Trials

Miricorilant Dose Escalation

CAM2029

Cotadutide

Side Effects for

Overall Study

21%Nausea

12%Decreased Appetite

This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04189848) in the Overall Study ARM group. Side effects include: Nausea with 21%, Decreased Appetite with 12%.

Trial Design

2 Treatment Groups

Semaglutide OW (once weekly )

1 of 2

Placebo

1 of 2

Experimental Treatment

Non-Treatment Group

1200 Total Participants · 2 Treatment Groups

Primary Treatment: Semaglutide · Has Placebo Group · Phase 3

Semaglutide OW (once weekly )

Drug

Experimental Group · 1 Intervention: Semaglutide · Intervention Types: Drug

Placebo

Drug

PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide

FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: from randomisation (week 0) to week 240

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,390 Previous Clinical Trials

2,292,403 Total Patients Enrolled

Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S

56 Previous Clinical Trials

52,667 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

You have histological evidence of non-alcoholic steatohepatitis based on a central pathologist evaluation of the baseline liver biopsy.

You have a histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN (Clinical Research Network) classification based on a central pathologist evaluation of the baseline liver biopsy.

About The Reviewer

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: November 1st, 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.