Clinical trial NCT03693430: Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Official title: Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly 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: 2018-10-03
Enrollment: 304
Sex: ALL
Standard ages: CHILD
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 body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. 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 2 years. The participants will have 19 clinic visits and 15 phone calls 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 (BMI) 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:

* HbA1c 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: Percentage Change From Baseline (Week 0) to Week 104 in Body Weight
timeFrame: From Baseline (Week 0) to Week 104
measure: Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%
timeFrame: At Week 104
Secondary outcomes:
measure: Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%
timeFrame: At Week 104
measure: Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%
timeFrame: At Week 104
measure: Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%
timeFrame: At Week 104
measure: Change From Baseline (Week 0) to Week 104 in Waist Circumference
timeFrame: From Baseline (Week 0) to Week 104
measure: Change From Baseline (Week 0) to Week 104 in Body Weight (kg)
timeFrame: From Baseline (Week 0) to Week 104
measure: Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI)
timeFrame: From Baseline (Week 0) to Week 104
measure: Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure
timeFrame: From Baseline (Week 0) to Week 104
measure: Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure
timeFrame: From Baseline (Week 0) to Week 104
measure: Change in Total Cholesterol-ratio to Baseline
timeFrame: From Baseline (Week 0) to Week 104
measure: Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline
timeFrame: From Baseline (Week 0) to Week 104
measure: Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline
timeFrame: From Baseline (Week 0) to Week 104
measure: Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline
timeFrame: From Baseline (Week 0) to Week 104
measure: Change in Free Fatty Acids-ratio to Baseline
timeFrame: From Baseline (Week 0) to Week 104
measure: Change in Triglycerides-ratio to Baseline
timeFrame: From Baseline (Week 0) to Week 104
measure: Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline
timeFrame: From Baseline (Week 0) to Week 104
measure: Change in Glycated Haemoglobin (HbA1c) (Percent [%])
timeFrame: From Baseline (Week 0) to Week 104
measure: Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol)
timeFrame: From Baseline (Week 0) to Week 104
measure: Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L)
timeFrame: From Baseline (Week 0) to Week 104
measure: Change From Baseline (Week 0) to Week 104 in FPG (mg/dL)
timeFrame: From Baseline (Week 0) to Week 104
measure: Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L)
timeFrame: From Baseline (Week 0) to Week 104
measure: Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL)
timeFrame: From Baseline (Week 0) to Week 104
measure: Percentage Change From Baseline (Week 0) to Week 52 in Body Weight
timeFrame: From Baseline (Week 0) to Week 52
measure: Change From Baseline (Week 0) to Week 52 in Body Weight (kg)
timeFrame: From Baseline (Week 0) to Week 52
measure: Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI)
timeFrame: From Baseline (Week 0) to Week 52
measure: Change From Baseline (Week 0) to Week 52 in Waist Circumference
timeFrame: From Baseline (Week 0) to Week 52
measure: Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%
timeFrame: At Week 52
measure: Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%
timeFrame: At Week 52
measure: Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%
timeFrame: At Week 52
measure: Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%
timeFrame: At Week 52
measure: Number of Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Baseline (Week 0) to Week 111
measure: Number of Serious Adverse Events (SAEs)
timeFrame: From Baseline (Week 0) to Week 111
measure: Change From Baseline (Week 0) to Week 104 in Pulse
timeFrame: From Baseline (Week 0) to Week 104
measure: Change From Baseline (Week 0) to Week 104 in Amylase
timeFrame: From Baseline (Week 0) to Week 104
measure: Change From Baseline (Week 0) to Week 104 in Lipase
timeFrame: From Baseline (Week 0) to Week 104
measure: Change From Baseline (Week 0) to Week 104 in Calcitonin
timeFrame: From Baseline (Week 0) to Week 104
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Aurora
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Golden
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Waterbury
country: United States
facility: Novo Nordisk Investigational Site
state: Connecticut
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Ocala
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Saint Peters
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Butte
country: United States
facility: Novo Nordisk Investigational Site
state: Montana
city: Albany
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Rochester
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Kingsport
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Arlington
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Surrey
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Moncton
country: Canada
facility: Novo Nordisk Investigational Site
state: New Brunswick
city: Halifax
country: Canada
facility: Novo Nordisk Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Debrecen
country: Hungary
facility: Novo Nordisk Investigational Site
city: Komarom
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szekszárd
country: Hungary
facility: Novo Nordisk Investigational Site
city: Bologna
country: Italy
facility: Novo Nordisk Investigational Site
city: Palermo
country: Italy
facility: Novo Nordisk Investigational Site
city: Pisa
country: Italy
facility: Novo Nordisk Investigational Site
city: Rome
country: Italy
facility: Novo Nordisk Investigational Site
city: Siena
country: Italy
facility: Novo Nordisk Investigational Site
city: Alcorcón
country: Spain
facility: Novo Nordisk Investigational Site
city: Almeria
country: Spain
facility: Novo Nordisk Investigational Site
city: Hospitalet de Llobregat
country: Spain
facility: Novo Nordisk Investigational Site
city: Pamplona
country: Spain
facility: Novo Nordisk Investigational Site
city: Pozuelo de Alarcon
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
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: Wharton S, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Garvey WT. Two-year effect of semaglutide 2.4 mg on control of eating in adults with overweight/obesity: STEP 5. Obesity (Silver Spring). 2023 Mar;31(3):703-715. doi: 10.1002/oby.23673. Epub 2023 Jan 18.
citation: Garvey WT, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Wharton S; STEP 5 Study Group. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022 Oct;28(10):2083-2091. doi: 10.1038/s41591-022-02026-4. Epub 2022 Oct 10.