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MK-3655 in Pre-cirrhotic NASH
NCT04583423Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2020
- Primary completion
- Apr 2023
- Countries
- 24
- Sponsor
- Merck & Co.
- Modality
- Monoclonal Antibodies
- Drugs
- NGM313
- Conditions
- Nonalcoholic steatohepatitis (NASH)
01
Overview
Phase 2, randomised, double-blind trial of NGM313 in Nonalcoholic steatohepatitis (NASH) (4 arms), sponsored by Merck & Co. Primary endpoints: Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis at 52 weeks, Percentage of Participants Who Experienced an Adverse Event at 64 weeks and 1 more. Started Nov 2020; status: terminated.
02
Design
4 arms- Study design
- RandomizedDouble-blind
MK-3655 50 mg
MK-3655 50 mg SC Q4W
MK-3655 100 mg
MK-3655 100 mg SC Q4W
MK-3655 300 mg
MK-3655 300 mg SC Q4W
Placebo
Placebo SC Q4W
03
Who it enrols
Adults with histologically confirmed pre-cirrhotic NASH, BMI 25-50, without cirrhosis or other chronic liver diseases.
04
Endpoints
Primary
Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis
Percentage of Participants Who Experienced an Adverse Event
Percentage of Participants Discontinuing Study Medication Due to an AE
Secondary
Mean Percent Relative Reduction From Baseline in Liver Fat Content (LFC)
Percentage of Participants With >=1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis
Percentage of Participants With >=2 Point Improvement in NAS With >=1 Point Improvement in Inflammation or Ballooning Without Worsening of Fibrosis
05
Results
Not all primary endpoints met
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