Clinical trial NCT03611582: Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program
Official title: Effect and Safety of Semaglutide 2.4 mg Once-weekly as Adjunct to Intensive Behavioural Therapy 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: 2018-08-02
Enrollment: 611
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. Together with the medicine, the participant will also be part of an intensive lifestyle program where the participant will have talks with study staff about healthy food choices, what the participant can do to lose weight and be more physically active. The participant will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. The participant 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. For the first 2 months the participant will be on a low calorie diet. The diet is made up of bars, shakes and 1 low calorie pre-prepared meal for each day. The study will last for about 1.5 years. The participant will have 32 clinic visits with the study doctor.


Eligibility criteria: Inclusion Criteria:

* Male or female, age more than or equal to 18 years at the time of signing informed consent
* Body mass index more than or equal to 30 kg/m\^2 or more than or equal to 27 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:

* Hemoglobin A1c more than or equal to 48 mmol/mol (6.5%) as measured by the 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 in Body Weight (%)
timeFrame: Baseline (week 0) to week 68
measure: Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%
timeFrame: After 68 weeks
Secondary outcomes:
measure: Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%
timeFrame: After 68 weeks
measure: Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%
timeFrame: After 68 weeks
measure: Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%
timeFrame: After 68 weeks
measure: Change in Waist Circumference
timeFrame: Baseline (week 0) to week 68
measure: Change in Systolic Blood Pressure
timeFrame: Baseline (week 0) to week 68
measure: Change in Short Form-36 (SF-36) - Physical Functioning Score
timeFrame: Baseline (week 0) to week 68
measure: Change in Body Weight (Kg)
timeFrame: Baseline (week 0) to week 68
measure: Change in Body Mass Index
timeFrame: Baseline (week 0) to week 68
measure: Change in HbA1c (%)
timeFrame: Baseline (week 0) to week 68
measure: Change in HbA1c (mmol/Mol)
timeFrame: Baseline (week 0) to week 68
measure: Change in Fasting Plasma Glucose
timeFrame: Baseline (week 0) to week 68
measure: Change in Fasting Serum Insulin
timeFrame: Baseline (week 0) to week 68
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline (week 0) to week 68
measure: Change in Total Cholesterol
timeFrame: Baseline (week 0) to week 68
measure: Change in High-density Lipoproteins (HDL)
timeFrame: Baseline (week 0) to week 68
measure: Change in Low-density Lipoproteins (LDL)
timeFrame: Baseline (week 0) to week 68
measure: Change in Very Low Density Lipoprotein (VLDL)
timeFrame: Baseline (week 0) to week 68
measure: Change in Free Fatty Acids
timeFrame: Baseline (week 0) to week 68
measure: Change in Triglycerides
timeFrame: Baseline (week 0) to week 68
measure: Change in High Sensitivity C-reactive Protein
timeFrame: Baseline (week 0) to week 68
measure: Change in Plasminogen Activator Inhibitor-1 Activity
timeFrame: Baseline (week 0) to week 68
measure: Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score
timeFrame: After 68 weeks
measure: Change in Body Weight
timeFrame: Baseline (week 0) to week 8
measure: Number of Treatment-emergent Adverse Events (AEs)
timeFrame: Baseline (week 0) to week 75
measure: Number of Serious Adverse Events (SAEs)
timeFrame: Baseline (week 0) to week 75
measure: Change in Pulse
timeFrame: Baseline (week 0) to week 68
measure: Change in Amylase
timeFrame: Baseline (week 0) to week 68
measure: Change in Lipase
timeFrame: Baseline (week 0) to week 68
measure: Change in Calcitonin
timeFrame: Baseline (week 0) to week 68
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Peoria
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Escondido
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
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: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Golden
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Kissimmee
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Panama City
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Plantation
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Roswell
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Novo Nordisk Investigational Site
state: Hawaii
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Evanston
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Albany
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Endwell
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Hickory
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: 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: Mount Pleasant
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Knoxville
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: Rockwall
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Saint George
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Arlington
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Newport News
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: 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: Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O'Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT; STEP 3 Investigators. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama.2021.1831.
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.