Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
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ClinicalTrials.gov Identifier: NCT02970942 |
Recruitment Status :
Completed
First Posted : November 22, 2016
Results First Posted : April 21, 2021
Last Update Posted : November 16, 2021
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Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Conditions |
Hepatobiliary Disorders Non-alcoholic Steatohepatitis |
Interventions |
Drug: Semaglutide Drug: Placebo |
Enrollment | 320 |
Participant Flow
Recruitment Details | The trial was conducted at 114 sites in 16 countries as follows (number of sites that screened participants/ number of sites that randomised participants): Australia (4/ 3); Austria (3/ 3); Belgium (4/ 4); Bulgaria (2/ 2); Canada (9/ 7); Denmark (2/ 2); Finland (1/ 1); France (8/ 6); Greece (5/ 5); Japan (13/ 12); Netherlands (7/ 5); Russian Federation (25/ 17); Spain (6/ 5); Sweden (3/ 2); United Kingdom (15/ 11); United States (36/ 29). |
Pre-assignment Details | Participants were randomised in a 3:3:3:1:1:1 ratio to receive once-daily semaglutide or placebo subcutaneously. After randomisation, the participants entered a dose-escalation period, with increase in dose every 4 weeks until the target dose was reached. |
Arm/Group Title | Semaglutide 0.1 mg | Semaglutide 0.2 mg | Semaglutide 0.4 mg | Placebo |
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Arm/Group Description | Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72). | Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72). | Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72). | Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks. |
Period Title: Overall Study | ||||
Started | 80 | 78 | 82 | 80 |
Full Analysis Set | 80 | 78 | 82 | 80 |
Safety Analysis Set | 80 | 78 | 81 | 80 |
Exposed | 80 | 78 | 81 | 80 |
Completed | 76 | 72 | 77 | 77 |
Not Completed | 4 | 6 | 5 | 3 |
Reason Not Completed | ||||
Death | 0 | 1 | 0 | 0 |
Lost to Follow-up | 1 | 0 | 2 | 1 |
Withdrawal by Subject | 3 | 5 | 3 | 2 |
Baseline Characteristics
Arm/Group Title | Semaglutide 0.1 mg | Semaglutide 0.2 mg | Semaglutide 0.4 mg | Placebo | Total | |
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Arm/Group Description | Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72). | Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72). | Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72). | Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 80 | 78 | 82 | 80 | 320 | |
Baseline Analysis Population Description |
The full analysis set included all randomised participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 80 participants | 78 participants | 82 participants | 80 participants | 320 participants | |
55.2 (10.9) | 58.1 (9.9) | 54.3 (10.2) | 52.4 (10.8) | 55.0 (10.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 80 participants | 78 participants | 82 participants | 80 participants | 320 participants | |
Female |
51 63.7%
|
52 66.7%
|
47 57.3%
|
44 55.0%
|
194 60.6%
|
|
Male |
29 36.3%
|
26 33.3%
|
35 42.7%
|
36 45.0%
|
126 39.4%
|
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 80 participants | 78 participants | 82 participants | 80 participants | 320 participants | |
Hispanic or Latino |
7 8.8%
|
10 12.8%
|
14 17.1%
|
9 11.3%
|
40 12.5%
|
|
Not Hispanic or Latino |
69 86.3%
|
63 80.8%
|
65 79.3%
|
66 82.5%
|
263 82.2%
|
|
Unknown or Not Reported |
4 5.0%
|
5 6.4%
|
3 3.7%
|
5 6.3%
|
17 5.3%
|
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 80 participants | 78 participants | 82 participants | 80 participants | 320 participants | |
American Indian or Alaska Native |
0 0.0%
|
1 1.3%
|
2 2.4%
|
0 0.0%
|
3 0.9%
|
|
Asian |
10 12.5%
|
12 15.4%
|
14 17.1%
|
12 15.0%
|
48 15.0%
|
|
Black or African American |
1 1.3%
|
1 1.3%
|
0 0.0%
|
0 0.0%
|
2 0.6%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
White |
65 81.3%
|
59 75.6%
|
62 75.6%
|
62 77.5%
|
248 77.5%
|
|
Other |
0 0.0%
|
0 0.0%
|
1 1.2%
|
1 1.3%
|
2 0.6%
|
|
Not applicable |
4 5.0%
|
5 6.4%
|
3 3.7%
|
5 6.3%
|
17 5.3%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Results Point of Contact
Name/Title: | Clinical Reporting Anchor and Disclosure (1452) |
Organization: | Novo Nordisk A/S |
Phone: | (+1) 866-867-7178 |
EMail: | clinicaltrials@novonordisk.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT02970942 |
Other Study ID Numbers: |
NN9931-4296 2016-000685-39 ( EudraCT Number ) U1111-1179-7464 ( Other Identifier: WHO ) |
First Submitted: | November 18, 2016 |
First Posted: | November 22, 2016 |
Results First Submitted: | February 11, 2021 |
Results First Posted: | April 21, 2021 |
Last Update Posted: | November 16, 2021 |