Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity (STEP 8)

• ClinicalTrials.gov Identifier: NCT04074161
• Recruitment Status: Active, not recruiting
• First Posted: August 29, 2019
• Last Update Posted: April 8, 2021
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Tracking Information

• First Submitted Date: August 28, 2019
• First Posted Date: August 29, 2019
• Last Update Posted Date: April 8, 2021
• Actual Study Start Date: September 11, 2019
• Actual Primary Completion Date: March 27, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 28, 2019)

Change in body weight [ Time Frame: From baseline (week 0) to week 68 ]

Percent

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 28, 2019)

• Subject who achieves body weight reduction equal to or above 10% (yes/no) [ Time Frame: From baseline (week 0) to week 68 ]
  Number of participants
• Subject who achieves body weight reduction equal to or above 15% (yes/no) [ Time Frame: From baseline (week 0) to week 68 ]
  Number of participants
• Subject who achieves body weight reduction equal to or above 20% (yes/no) [ Time Frame: From baseline (week 0) to week 68 ]
  Number of participants
• Change in waist circumference [ Time Frame: From baseline (week 0) to week 68 ]
  cm
• Change in body weight (semaglutide s.c. 2.4 mg once-weekly versus placebo and liraglutide s.c. 3.0 mg once-daily versus placebo) [ Time Frame: From baseline (week 0) to week 68 ]
  Percent
• Change in systolic blood pressure [ Time Frame: From baseline (week 0) to week 68 ]
  mmHg
• Change in total cholesterol [ Time Frame: From baseline (week 0) to week 68 ]
  mg/dL
• Change in high density lipoprotein (HDL) cholesterol [ Time Frame: From baseline (week 0) to week 68 ]
  mg/dL
• Change in low density lipoprotein (LDL) cholesterol [ Time Frame: From baseline (week 0) to week 68 ]
  mg/dL
• Change in very low density lipoprotein (VLDL) cholesterol [ Time Frame: From baseline (week 0) to week 68 ]
  mg/dL
• Change in free fatty acids (FFA) [ Time Frame: From baseline (week 0) to week 68 ]
  mg/dL
• Change in triglycerides [ Time Frame: From baseline (week 0) to week 68 ]
  mg/dL
• Change in high-sensitivity C-reactive protein (hs-CRP) [ Time Frame: From baseline (week 0) to week 68 ]
  mg/L
• Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to week 68 ]
  Percent
• Change in fasting plasma glucose [ Time Frame: From baseline (week 0) to week 68 ]
  mg/dL
• Change in glycaemic category (normo-glycaemia, pre-diabetes, T2D) [ Time Frame: From baseline (week 0) to week 68 ]
  Number of participants
• Subjects who have permanently discontinued randomised trial product (yes/no) [ Time Frame: From baseline (week 0) to week 68 ]
  Number of participants
• Number of treatment emergent adverse events (TEAEs) [ Time Frame: From baseline (week 0) to week 75 ]
  Count
• Number of serious adverse events (SAEs) [ Time Frame: From baseline (week 0) to week 75 ]
  Count

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity
• Official Title: Effect and Safety of Subcutaneous Semaglutide 2.4 mg Once Weekly Compared to Liraglutide 3.0 mg Once Daily on Weight Management in Subjects With Overweight or Obesity
• Brief Summary: This study will look at participants' body weight from the start to the end of the study. The study will last for about 1½ years. This is to compare the effect on body weight in people taking semaglutide once a week or people taking liraglutide once every day. Participants will either get semaglutide, liraglutide or "dummy" medicine. Which treatment is decided by chance. Participants who receive semaglutide or semaglutide "dummy" medicine will need to take 1 injection once a week. Participants who receive liraglutide or liraglutide "dummy" medicine will need to take 1 injection once daily. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study participants will have talks with study staff about eating healthy food and how to be more physically active. Participants will have 16 clinic visits and 7 phone calls with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Semaglutide once weekly vs liraglutide once daily treatment will be open label, but each of the two active treatment arms will be double blinded against placebo administered at the same dosing frequency.

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Primary Purpose: Treatment

Condition

• Overweight
• Obesity

Intervention

• Drug: Semaglutide
  Dose gradually increased to 2.4 mg administered once weekly for 68 weeks
• Drug: Placebo (semaglutide)
  Administered once weekly for 68 weeks
• Drug: Liraglutide
  Dose gradually increased to 3.0 mg administered once daily for 68 weeks
• Drug: Placebo (liraglutide)
  Administered once daily for 68 weeks

Study Arms

• Experimental: Semaglutide
  Semaglutide administered s.c. (subcutaneously, under the skin) adjunct to a reduced-calorie diet and increased physical activity
  Intervention: Drug: Semaglutide
• Placebo Comparator: Placebo (semaglutide)
  Placebo (semaglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity
  Intervention: Drug: Placebo (semaglutide)
• Active Comparator: Liraglutide
  Liraglutide administered s.c. adjunct to a reduced-calorie diet and increased physical activity
  Intervention: Drug: Liraglutide
• Placebo Comparator: Placebo (liraglutide)
  Placebo (liraglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity
  Intervention: Drug: Placebo (liraglutide)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 11, 2020): 338
• Original Estimated Enrollment (submitted: August 28, 2019): 336
• Estimated Study Completion Date: May 12, 2021
• Actual Primary Completion Date: March 27, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male or female, age 18 years or older at the time of signing informed consent
• Body mass index (BMI) equal to or above 30.0 kg/m^2 or equal to or above 27.0 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
• History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

• HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening
• History of type 1 or type 2 diabetes mellitus
• A self-reported change in body weight of more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04074161
• Other Study ID Numbers: NN9536-4576; U1111-1233-0977 ( Other Identifier: World Health Organization (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

• Plan to Share IPD: Yes
• Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
• URL: http://novonordisk-trials.com

• Responsible Party: Novo Nordisk A/S
• Study Sponsor: Novo Nordisk A/S
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452); Novo Nordisk A/S

• PRS Account: Novo Nordisk A/S
• Verification Date: April 2021