Trial · NCT02970942
Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
NCT02970942, Phase 2, Completed, Novo Nordisk A/S; results first posted 2021-04-21
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis. Trials, record NCT02970942. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02970942
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
- NCT number
- NCT02970942
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 320 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Hepatobiliary Disorders, Non-alcoholic Steatohepatitis
- Interventions
- Semaglutide, Placebo
- First posted
- 2016-11-22
- Last updated
- 2021-11-16
- Other registries' IDs
- eudract:2016-000685-39
- Results first posted
- 2021-04-21
Source ClinicalTrials.gov
Registered outcomes88
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) | After 72 weeks | NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. |
| Secondary | Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No) | After 72 weeks | NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning range: 0-2; lobular inflammation range: 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicate greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3)last contact with participant (for participants lost to follow-up); 4)death. |
| Secondary | Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS) | Baseline (week 0), Week 72 | Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 72 is presented. Worsening is defined as an increase of at least 1 in the NAS; Improvement is defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS from baseline to week 72. NAS is calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. |
| Secondary | Percentage of Participants With Change in Steatosis | Baseline (week 0), Week 72 | Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 72 is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. |
| Secondary | Percentage of Participants With Change in Lobular Inflammation | Baseline (week 0), Week 72 | Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 72 is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. |
| Secondary | Percentage of Participants With Change in Hepatocyte Ballooning | Baseline (week 0), Week 72 | Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 72 is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. |
| Secondary | Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification | Baseline (week 0), Week 72 | Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 72 is presented. The degree of fibrosis is described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. |
| Secondary | Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score | Baseline (week 0), Week 72 | Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 72 is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. |
| Secondary | Change in Fibrosis-4 Score | Baseline (week 0), Week 72 | Change in fibrosis-4 score is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: Fibrosis-4 = (Age \[years\] x AST \[U/L\]) / (platelets \[10\^9/L\] x (square root of ALT \[U/L\])). A Fibrosis-4 index of \< 1.45 indicated no or moderate fibrosis and an index of \> 3.25 indicated extensive fibrosis/cirrhosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. |
| Secondary | Change in NAFLD Fibrosis Score (NFS) | Baseline (week 0), Week 72 | Change in NFS from baseline to week 72 is presented. NFS is calculated using formula: NFS = -1.675 + 0.037 \* age (years) + 0.094 \* body mass index (BMI) (kg/m\^2) + 1.13 \* hyperglycaemia (yes/no) + 0.99 \* Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio + 0.013 × platelet count (\*10\^9/L) - 0.66 \* albumin (g/dL). The score is used to classify the probability of fibrosis. A score a) \< -1.5 indicates a low probability, b) \> -1.5 to \< 0.67 indicates intermediate probability, and a score of c) \> 0.67 indicates a high probability of liver fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 registered outcomesOutcomes88
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) | After 72 weeks | Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with fibrosis stage 2 or 3 at baseline who contributed to the analysis. In below table, 'Yes' infers percentage of participants who achieved NASH resolution without worsening of fibrosis and 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No) | After 72 weeks | Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with fibrosis stage 2 or 3 at baseline who contributed to the analysis. In below table, 'Yes' infers percentage of participants who achieved at least one stage of fibrosis improvement with no worsening of NASH; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS) | Baseline (week 0), Week 72 | Full analysis set included all randomised participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Change in Steatosis | Baseline (week 0), Week 72 | Full analysis set included all randomised participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Change in Lobular Inflammation | Baseline (week 0), Week 72 | Full analysis set included all randomised participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Change in Hepatocyte Ballooning | Baseline (week 0), Week 72 | Full analysis set included all randomised participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification | Baseline (week 0), Week 72 | Full analysis set included all randomised participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score | Baseline (week 0), Week 72 | Full analysis set included all randomised participants. | Percentage of participants | NUMBER |
| SECONDARY | Change in Fibrosis-4 Score | Baseline (week 0), Week 72 | Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Ratio of fibrosis-4 score | GEOMETRIC_MEAN |
| SECONDARY | Change in NAFLD Fibrosis Score (NFS) | Baseline (week 0), Week 72 | Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis. | Score on a scale | MEAN |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 outcomesResults by group724
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) | Semaglutide 0.1 mg | Yes | 40.4 | Percentage of participants | |
| Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) | Semaglutide 0.2 mg | Yes | 35.6 | Percentage of participants | |
| Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) | Semaglutide 0.4 mg | Yes | 58.9 | Percentage of participants | |
| Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) | Placebo | Yes | 17.2 | Percentage of participants | |
| Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) | Semaglutide 0.1 mg | No | 54.4 | Percentage of participants | |
| Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) | Semaglutide 0.2 mg | No | 47.5 | Percentage of participants | |
| Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) | Semaglutide 0.4 mg | No | 30.4 | Percentage of participants | |
| Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) | Placebo | No | 74.1 | Percentage of participants | |
| Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) | Semaglutide 0.1 mg | Missing | 5.3 | Percentage of participants | |
| Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) | Semaglutide 0.2 mg | Missing | 16.9 | Percentage of participants |
1 to 10 of 724Source ClinicalTrials.gov
See all 724 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Semaglutide 0.1 mg | 80 | |
| Overall Study | STARTED | Semaglutide 0.2 mg | 78 | |
| Overall Study | STARTED | Semaglutide 0.4 mg | 82 | |
| Overall Study | STARTED | Placebo | 80 | |
| Overall Study | Full Analysis Set | Semaglutide 0.1 mg | 80 | |
| Overall Study | Full Analysis Set | Semaglutide 0.2 mg | 78 | |
| Overall Study | Full Analysis Set | Semaglutide 0.4 mg | 82 | |
| Overall Study | Full Analysis Set | Placebo | 80 | |
| Overall Study | Safety Analysis Set | Semaglutide 0.1 mg | 80 | |
| Overall Study | Safety Analysis Set | Semaglutide 0.2 mg | 78 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events380
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Semaglutide 0.1 mg | 1 | 80 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Semaglutide 0.2 mg | 8 | 78 | 9 |
| other | Abdominal distension | Gastrointestinal disorders | Semaglutide 0.4 mg | 4 | 81 | 7 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 4 | 80 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Semaglutide 0.1 mg | 9 | 80 | 10 |
| other | Abdominal pain | Gastrointestinal disorders | Semaglutide 0.2 mg | 8 | 78 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | Semaglutide 0.4 mg | 6 | 81 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 3 | 80 | 4 |
| other | Abdominal pain upper | Gastrointestinal disorders | Semaglutide 0.1 mg | 5 | 80 | 5 |
| other | Abdominal pain upper | Gastrointestinal disorders | Semaglutide 0.2 mg | 6 | 78 | 7 |
1 to 10 of 380Source ClinicalTrials.gov
See all 380 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Semaglutide 0.1 mg | 0 | 80 |
| Total, all-cause mortality | Semaglutide 0.2 mg | 1 | 78 |
| Total, all-cause mortality | Semaglutide 0.4 mg | 0 | 81 |
| Total, all-cause mortality | Placebo | 0 | 80 |
| Total, other adverse events | Semaglutide 0.1 mg | 61 | 80 |
| Total, other adverse events | Semaglutide 0.2 mg | 64 | 78 |
| Total, other adverse events | Semaglutide 0.4 mg | 63 | 81 |
| Total, other adverse events | Placebo | 55 | 80 |
| Total, serious adverse events | Semaglutide 0.1 mg | 12 | 80 |
| Total, serious adverse events | Semaglutide 0.2 mg | 15 | 78 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02970942
GET https://conductscience.org/api/trials/v1/NCT02970942/registered?page=2