Clinical trial NCT04074161: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-08-29
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)
timeFrame: Baseline (week 0), week 68
Secondary outcomes:
measure: Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)
timeFrame: From baseline (week 0) to week 68
measure: Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no)
timeFrame: From baseline (week 0) to week 68
measure: Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no)
timeFrame: From baseline (week 0) to week 68
measure: Change From Baseline (Week 0) to Week 68 in Waist Circumference
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Pooled Placebo and Liraglutide 3.0 mg Versus Pooled Placebo)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol))
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D))
timeFrame: Baseline (week 0), week 68
measure: Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product
timeFrame: From baseline (week 0) to week 68
measure: Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75
timeFrame: From baseline (week 0) to week 75
measure: Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75
timeFrame: From baseline (week 0) to week 75
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Fullerton
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Huntington Beach
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Plantation
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Honolulu
country: United States
facility: Novo Nordisk Investigational Site
state: Hawaii
city: Evanston
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Baton Rouge
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Albany
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Wilmington
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Rockwall
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Arlington
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Winchester
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Olympia
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Wharton S, Davies M, Dicker D, Lingvay I, Mosenzon O, Rubino DM, Pedersen SD. Managing the gastrointestinal side effects of GLP-1 receptor agonists in obesity: recommendations for clinical practice. Postgrad Med. 2022 Jan;134(1):14-19. doi: 10.1080/00325481.2021.2002616. Epub 2021 Nov 29.
citation: Rubino DM, Greenway FL, Khalid U, O'Neil PM, Rosenstock J, Sorrig R, Wadden TA, Wizert A, Garvey WT; STEP 8 Investigators. Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial. JAMA. 2022 Jan 11;327(2):138-150. doi: 10.1001/jama.2021.23619.
citation: Snitker S, Egebjerg C, Frederiksen M, Sparre T. Ease-of-use and acceptability of the novel semaglutide 2.4 mg single-dose pen-injector in people with overweight or obesity in the STEP 8 phase III trial. Diabetes Obes Metab. 2022 Nov;24(11):2273-2276. doi: 10.1111/dom.14809. Epub 2022 Aug 7. No abstract available.