Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program (STEP 3)
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ClinicalTrials.gov Identifier: NCT03611582 |
Recruitment Status :
Completed
First Posted : August 2, 2018
Results First Posted : July 9, 2021
Last Update Posted : November 11, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Overweight Obesity |
Interventions |
Drug: Semaglutide Drug: Placebo (semaglutide) |
Enrollment | 611 |
Participant Flow
Recruitment Details | The trial was conducted in 41 sites in the United States. |
Pre-assignment Details | The trial has a 68-week treatment period (16 weeks of dose escalation and 52 weeks of maintenance dose). Participants were randomised in 2:1 ratio either to receive semaglutide 2.4 mg or placebo. |
Arm/Group Title | Semaglutide 2.4 mg | Placebo |
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Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment. | Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment. |
Period Title: Overall Study | ||
Started | 407 | 204 |
Full Analysis Set (FAS) | 407 | 204 |
Safety Analysis Set (SAS) | 407 | 204 |
Completed | 339 | 166 |
Not Completed | 68 | 38 |
Reason Not Completed | ||
Adverse Event | 26 | 6 |
Protocol Violation | 0 | 1 |
Pregnancy | 1 | 2 |
Lack of Efficacy | 0 | 1 |
At the discretion of the investigator | 1 | 0 |
Safety concern as judged by the investigator | 1 | 2 |
Withdrawal by Subject | 4 | 3 |
Lost to Follow-up | 18 | 7 |
other | 17 | 16 |
Baseline Characteristics
Arm/Group Title | Semaglutide 2.4 mg | Placebo | Total | |
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Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment. | Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment. | Total of all reporting groups | |
Overall Number of Baseline Participants | 407 | 204 | 611 | |
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Full analysis set (FAS) included all randomised participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 407 participants | 204 participants | 611 participants | |
46 (13) | 46 (13) | 46 (13) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 407 participants | 204 participants | 611 participants | |
Female |
315 77.4%
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180 88.2%
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495 81.0%
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Male |
92 22.6%
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24 11.8%
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116 19.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 407 participants | 204 participants | 611 participants | |
Hispanic or Latino |
75 18.4%
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46 22.5%
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121 19.8%
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Not Hispanic or Latino |
332 81.6%
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158 77.5%
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490 80.2%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 407 participants | 204 participants | 611 participants | |
American Indian or Alaska Native |
1 0.2%
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0 0.0%
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1 0.2%
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Asian |
5 1.2%
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6 2.9%
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11 1.8%
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Native Hawaiian or Other Pacific Islander |
3 0.7%
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0 0.0%
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3 0.5%
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Black or African American |
80 19.7%
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36 17.6%
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116 19.0%
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White |
307 75.4%
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158 77.5%
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465 76.1%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
11 2.7%
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4 2.0%
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15 2.5%
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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: | NCT03611582 |
Other Study ID Numbers: |
NN9536-4375 U1111-1200-8199 ( Other Identifier: World Health Organization (WHO) ) |
First Submitted: | July 17, 2018 |
First Posted: | August 2, 2018 |
Results First Submitted: | June 16, 2021 |
Results First Posted: | July 9, 2021 |
Last Update Posted: | November 11, 2021 |