| Trial ID: | L0413 |
| Source ID: | EUCTR2019-003048-63-DE
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| Associated Drug: |
MK-3655
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| Title: |
A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.
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| Acronym: |
--
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| Status: |
Authorised
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
<br>MedDRA version: 24.1
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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| Interventions: |
<br>Product Name: MK-3655<br>Product Code: MK-3655<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: not available<br>Current Sponsor code: MK-3655<br>Other descriptive name: BTPH-040, NP313, NGM313<br>Concentration unit: mg/ml millig
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| Outcome Measures: |
Main Objective: 1. To evaluate the effect of each dose of MK-3655 versus placebo on the proportion of individuals with nonalcoholic steatohepatitis (NASH) resolution without worsening of fibrosis after 52 weeks.<br>2. To evaluate the safety and tolerability of MK-3655 compared with placebo.;Secondary Objective: 1. To evaluate the effect of each dose of MK-3655 versus placebo on mean percent relative reduction from baseline in liver fat content (LFC) after 24 weeks.<br>2. To evaluate the effect of each dose of MK-3655 versus placebo on the proportion of individuals with =1 stage improvement in fibrosis without worsening of steatohepatitis after 52 weeks.<br>3. To evaluate the effect of each dose of MK-3655 versus placebo on the proportion of individuals with =2 point improvement in the Nonalcoholic Fatty Liver Disease Activity Score (NAS) without worsening of fibrosis after 52 weeks.<br>;Primary end point(s): 1. Percentage of participants with NASH resolution without worsening fibrosis assessed with the NASH Clinical Research Network (CRN) scoring system (evaluated by blinded independent central review [BICR]) after 52 weeks<br>2. Percentage of participants with adverse events (AEs) up to 56 weeks<br>3. Percentage of participants discontinuing study intervention due to adverse events (AEs) up to 52 weeks<br><br>;Timepoint(s) of evaluation of this end point: 1. At 52 weeks <br>2. Up to 56 weeks<br>3. Up to 52 weeks<br>Secondary end point(s): 1. Change from baseline in liver fat content (LFC) (%) measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF) (evaluated by BICR) after 24 weeks<br>2. Percentage of participants with =1 stage improvement in fibrosis without worsening of steatohepatitis assessed with the NASH CRN scoring system (evaluated by BICR) after 52 weeks<br>3. Percentage of participants with =2 point improvement (PI) in the Nonalcoholic Fatty Liver Disease Activity Score (NAS) with =1 PI in inflammation/ballooning without worsening fibrosis by NASH CRN scoring system (evaluated by BICR) after 52 weeks<br>;Timepoint(s) of evaluation of this end point: 1. Baseline and 24 Weeks<br>2. At 52 weeks<br>3. At 52 weeks<br>
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| Sponsor/Collaborators: |
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 2
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| Enrollment: |
328
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of trea
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| Start Date: |
04/09/2020
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
13 December 2021
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| Locations: |
United States;Taiwan;Hong Kong;Greece;Spain;Turkey;Russian Federation;Chile;Israel;Colombia;Italy;France;Mexico;Puerto Rico;Canada;Argentina;Australia;Germany;New Zealand;Japan;China;Sweden;Korea, Republic of
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-003048-63
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