Clinical trial NCT03548987: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Official title: Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity Who Have Reached Target Dose During run-in Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-06-07
Enrollment: 902
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 the change in participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight.

The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years.


Eligibility criteria: Inclusion Criteria:

* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Body mass index greater than or equal to 30 kg/sqm or greater than or equal to 27 kg/sqm 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:

* Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by central laboratory at screening
* A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Primary outcomes:
measure: Change From Randomisation to Week 68 in Body Weight (%)
timeFrame: Randomisation (week 20) to week 68
Secondary outcomes:
measure: Change in Waist Circumference
timeFrame: Randomization (week 20) to week 68
measure: Change in Systolic Blood Pressure
timeFrame: Randomization (week 20) to week 68
measure: Change in Diastolic Blood Pressure
timeFrame: Randomization (week 20) to week 68
measure: Change in Physical Functioning Score (Short Form 36 [SF-36])
timeFrame: Randomization (week 20) to week 68
measure: Change in Body Weight [Kilogram (Kg)]
timeFrame: Randomisation (week 20) to week 68
measure: Change in Body Mass Index (BMI)
timeFrame: Randomization (week 20) to week 68
measure: Change in Haemoglobin A1c (HbA1c) [%]
timeFrame: Randomization (week 20) to week 68
measure: Change in HbA1c [Millimoles Per Mole (mmol/Mol)]
timeFrame: Randomization (week 20) to week 68
measure: Change in Fasting Plasma Glucose [Milligrams Per Deciliter (mg/dL)]
timeFrame: Randomization (week 20) to week 68
measure: Change in Fasting Plasma Glucose [Millimoles Per Litre (mmol/L)]
timeFrame: Randomization (week 20) to week 68
measure: Change in Fasting Serum Insulin
timeFrame: Randomization (week 20) to week 68
measure: Change in Total Cholesterol
timeFrame: Randomization (week 20) to week 68
measure: Change in High-density Lipoproteins (HDL)
timeFrame: Randomization (week 20) to week 68
measure: Change in Low-density Lipoproteins (LDL)
timeFrame: Randomization (week 20) to week 68
measure: Change in Very Low-density Lipoproteins (VLDL)
timeFrame: Randomization (week 20) to week 68
measure: Change in Free Fatty Acids
timeFrame: Randomization (week 20) to week 68
measure: Change in Triglycerides
timeFrame: Randomization (week 20) to week 68
measure: Subjects Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score
timeFrame: Randomisation (week 20) to week 68
measure: Subjects Who Gain Weight (Yes/no)
timeFrame: Randomisation (week 20) to week 68
measure: Change in Body Weight
timeFrame: Run-in (week 0) to week 68
measure: Subjects Who Achieve (Yes/no): Body Weight Reduction < 0%
timeFrame: Run-in (week 0) to week 68
measure: Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 5%
timeFrame: Run-in (week 0) to week 68
measure: Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 10%
timeFrame: Run-in (week 0) to week 68
measure: Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 15%
timeFrame: Run-in (week 0) to week 68
measure: Number of Treatment-emergent Adverse Events (AEs)
timeFrame: Run-in (week 0) to randomisation (week 20)
measure: Number of Treatment-emergent AEs
timeFrame: Randomisation (week 20) to week 75
measure: Number of Serious Adverse Events (SAEs)
timeFrame: Run-in (week 0) to randomisation (week 20)
measure: Number of Serious Adverse Events (SAEs)
timeFrame: Randomisation (week 20) to week 75
measure: Change in Pulse
timeFrame: Run-in (week 0) to randomisation (week 20)
measure: Change in Pulse
timeFrame: Randomisation (week 20) to week 68
measure: Change in Amylase
timeFrame: Run-in (week) 0 to randomization (week 20)
measure: Change in Amylase
timeFrame: Randomisation (week 20) to week 68
measure: Change in Lipase
timeFrame: Run-in (week 0) to randomization (week 20)
measure: Change in Lipase
timeFrame: Randomisation (week 20) to week 68
measure: Change in Calcitonin
timeFrame: Run-in (week 0) to randomization (week 20)
measure: Change in Calcitonin
timeFrame: Randomisation (week 20) to week 68
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Diego
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Alpharetta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Suwanee
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Louisville
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Elkridge
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Buckley
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Omaha
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Greensboro
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Bristol
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Bristol
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
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: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Arlington
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Wenatchee
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Frederiksberg C
country: Denmark
facility: Novo Nordisk Investigational Site
city: Køge
country: Denmark
facility: Novo Nordisk Investigational Site
city: Haifa
country: Israel
facility: Novo Nordisk Investigational Site
city: Jerusalem
country: Israel
facility: Novo Nordisk Investigational Site
city: Kfar Saba
country: Israel
facility: Novo Nordisk Investigational Site
city: Petah-Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel Hashomer
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel-Aviv
country: Israel
facility: Novo Nordisk Investigational Site
city: Amsterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Amsterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Arnhem
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Braga
country: Portugal
facility: Novo Nordisk Investigational Site
city: Coimbra
country: Portugal
facility: Novo Nordisk Investigational Site
city: Matosinhos
country: Portugal
facility: Novo Nordisk Investigational Site
city: Porto
country: Portugal
facility: Novo Nordisk Investigational Site
city: Porto
country: Portugal
facility: Novo Nordisk Investigational Site
city: Vila Nova de Gaia
country: Portugal
facility: Novo Nordisk Investigational Site
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Brits
country: South Africa
facility: Novo Nordisk Investigational Site
state: North West
city: Almeria
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Sabadell
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Uppsala
country: Sweden
facility: Novo Nordisk Investigational Site
city: Genève 14
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Olten
country: Switzerland
facility: Novo Nordisk Investigational Site
city: St. Gallen
country: Switzerland
facility: Novo Nordisk Investigational Site
city: St. Gallen
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Zollikerberg
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Zürich
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Kharkiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kyiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kyiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kyiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Odesa
country: Ukraine
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, Wadden TA, Wharton S, Wilding JPH, Rubino D. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794.
citation: Rubino D, Abrahamsson N, Davies M, Hesse D, Greenway FL, Jensen C, Lingvay I, Mosenzon O, Rosenstock J, Rubio MA, Rudofsky G, Tadayon S, Wadden TA, Dicker D; STEP 4 Investigators. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1414-1425. doi: 10.1001/jama.2021.3224.
citation: Kosiborod MN, Bhatta M, Davies M, Deanfield JE, Garvey WT, Khalid U, Kushner R, Rubino DM, Zeuthen N, Verma S. Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. Diabetes Obes Metab. 2023 Feb;25(2):468-478. doi: 10.1111/dom.14890. Epub 2022 Oct 28.
citation: Perreault L, Davies M, Frias JP, Laursen PN, Lingvay I, Machineni S, Varbo A, Wilding JPH, Wallenstein SOR, le Roux CW. Changes in Glucose Metabolism and Glycemic Status With Once-Weekly Subcutaneous Semaglutide 2.4 mg Among Participants With Prediabetes in the STEP Program. Diabetes Care. 2022 Oct 1;45(10):2396-2405. doi: 10.2337/dc21-1785.
citation: O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.