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Trial record 2 of 22 for:    semaglutide + STEP 3 | Phase 3

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

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

Tracking Information
First Submitted Date  ICMJE August 28, 2019
First Posted Date  ICMJE August 29, 2019
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE September 11, 2019
Actual Primary Completion Date March 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
Change in body weight [ Time Frame: From baseline (week 0) to week 68 ]
Percent
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  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 Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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  ICMJE
  • Overweight
  • Obesity
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   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 11, 2020)
338
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2019)
336
Estimated Study Completion Date  ICMJE May 12, 2021
Actual Primary Completion Date March 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04074161
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date April 2021

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