Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 11002 for:    Placebo AND once

Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02970942
Recruitment Status : Active, not recruiting
First Posted : November 22, 2016
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE November 18, 2016
First Posted Date  ICMJE November 22, 2016
Last Update Posted Date October 17, 2019
Actual Study Start Date  ICMJE November 30, 2016
Estimated Primary Completion Date November 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
NASH (non-alcoholic steatohepatitis) resolution without worsening of fibrosis [ Time Frame: After 72 weeks ]
(yes/no)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02970942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
  • At least one stage of liver fibrosis improvement with no worsening of NASH [ Time Frame: After 72 weeks ]
    Worsening defined as an increase of at least one stage of either lobular inflammation or hepatocyte ballooning according to NASH clinical research network (CRN) criteria (yes/no)
  • Non-alcoholic fatty liver disease (NAFLD) activity score (NAS) (0-8) [ Time Frame: Week 0, week 72 ]
  • Stage of fibrosis according to the Kleiner fibrosis classification (0-4) [ Time Frame: Week 0, week 72 ]
  • Activity component of steatosis-activity-fibrosis (SAF) score (0-4) [ Time Frame: Week 0, week 72 ]
  • Fasting plasma glucose (FPG) [ Time Frame: Week 0, week 72 ]
  • Glycosylated haemoglobin A1c (HbA1c) [ Time Frame: Week 0, week 72 ]
  • Serum enhanced liver fibrosis (ELF) [ Time Frame: Week 0, week 72 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
Official Title  ICMJE This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis
Brief Summary Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatobiliary Disorders
  • Non-alcoholic Steatohepatitis
Intervention  ICMJE
  • Drug: Semaglutide
    Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)
  • Drug: Placebo
    Once daily administration subcutaneously ( s.c., under the skin)
Study Arms  ICMJE
  • Experimental: Semaglutide 0,1 mg
    Intervention: Drug: Semaglutide
  • Experimental: Semaglutide 0,2 mg
    Intervention: Drug: Semaglutide
  • Experimental: Semaglutide 0,4 mg
    Intervention: Drug: Semaglutide
  • Placebo Comparator: Placebo 1
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo 2
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo 3
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 14, 2019)
320
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2016)
372
Estimated Study Completion Date  ICMJE April 2, 2020
Estimated Primary Completion Date November 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial except for protocol described pre-screening activities which require a separate informed consent. - Male or female, aged 18-75 years (both inclusive) (for Japan: male or female aged 20-75 years (both inclusive)) at the time of signing informed consent - Local histological diagnosis of NASH followed by histological confirmation of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening - Histologic evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. - NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation Exclusion Criteria: - Known or suspected abuse of alcohol (above 20 g/day for women or above 30 g/day for men), alcohol dependence* or narcotics. (* = assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)) - Diagnosis of type 1 diabetes according to medical records - HbA1c above 10% at screening - History or presence of pancreatitis (acute or chronic) - Calcitonin equal or above 50 ng/L at screening - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - Body Mass Index (BMI) ≤ 25.0 kg/sqm at the screening visit (visit 1) - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Denmark,   Finland,   France,   Greece,   Japan,   Netherlands,   Puerto Rico,   Russian Federation,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02970942
Other Study ID Numbers  ICMJE NN9931-4296
2016-000685-39 ( EudraCT Number )
U1111-1179-7464 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to Novo Nordisk disclosure commitment on novonordisk.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novo Nordisk A/S
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP