Clinical trial NCT03811574: STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity
Official title: Effect and Safety of Semaglutide Once-weekly in East Asian 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: 2019-01-22
Enrollment: 401
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 participants' 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, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants are three times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a half years. Participants will have 14 clinic visits and 11 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
* BMI more than or equal to 27.0 kg/m\^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m\^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D)
* History of at least one self-reported unsuccessful dietary effort to lose body weight
* For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)

Exclusion Criteria:

* A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
* For subjects with T2D at screening (Japan only): a) Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m\^2 (less than 60 mL/min/1.73 m\^2 in subjects treated with sodium-glucose co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening. b) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation

Primary outcomes:
measure: Change in Body Weight (%)
timeFrame: Baseline (week 0), week 68
measure: Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%
timeFrame: At week 68
Secondary outcomes:
measure: Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%
timeFrame: At week 68
measure: Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%
timeFrame: At week 68
measure: Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%
timeFrame: At week 68
measure: Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest
timeFrame: Baseline (week 0) to week 68
measure: Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline
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 (BMI)
timeFrame: Baseline (week 0) to week 68
measure: Change in Visceral Fat Area (VFA) (%)
timeFrame: Baseline (week 0) to week 68
measure: Change in Visceral Fat Area (VFA) Centimeter Square (cm^2)
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-ratio to Baseline
timeFrame: Baseline (week 0) to week 68
measure: Change in Systolic Blood Pressure
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-ratio to Baseline
timeFrame: Baseline (week 0) to week 68
measure: Change in High-density Lipoproteins (HDL)-Ratio to Baseline
timeFrame: Baseline (week 0) to week 68
measure: Change in Low-density Lipoproteins (LDL)-Ratio to Baseline
timeFrame: Baseline (week 0) to week 68
measure: Change in Very Low-density Lipoproteins (VLDL)-Ratio to Baseline
timeFrame: Baseline (week 0) to week 68
measure: Change in Free Fatty Acids-ratio to Baseline
timeFrame: Baseline (week 0) to week 68
measure: Change in Triglycerides-ratio to Baseline
timeFrame: Baseline (week 0) to week 68
measure: Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline
timeFrame: Baseline (week 0) to week 68
measure: Change in Plasminogen Activator Inhibitor-1 Activity-ratio to Baseline
timeFrame: Baseline (week 0) to week 68
measure: Change in Short Form 36 v2.0 Acute (SF-36) Score
timeFrame: Baseline (week 0) to week 68
measure: Change in Impact of Weight on Quality of Life-lite for Clinical Trials (IWQOL-Lite for CT) Score
timeFrame: Baseline (week 0) to week 68
measure: Number of Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score
timeFrame: At week 68
measure: Number of Participants Who Achieve (Yes/no): Responder Definition Value for IWQoL-Lite for CT Physical Function (5-items) Score
timeFrame: At week 68
measure: Number of Participants Who Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol)
timeFrame: At week 68
measure: Number of Participants Who Achieved (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)
timeFrame: At week 68
measure: Number of Treatment-emergent AEs
timeFrame: Week 0 to week 75
measure: Number of Serious Adverse Events
timeFrame: Week 0 to week 75
measure: Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes
timeFrame: Week 0 to week 75
measure: Change in Pulse
timeFrame: Baseline (week 0) to week 68
measure: Change in Amylase: Ratio to Baseline
timeFrame: Baseline (week 0) to week 68
measure: Change in Lipase: Ratio to Baseline
timeFrame: Baseline (week 0) to week 68
measure: Change in Calcitonin: Ratio to Baseline
timeFrame: Baseline (week 0) to week 68
measure: Change in QTCF Interval
timeFrame: Baseline (week 0) to week 68
Other outcomes:
Locations:
city: Adachi-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Bunkyo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chitose, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku,Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Gunma
country: Japan
facility: Novo Nordisk Investigational Site
city: Ibaraki
country: Japan
facility: Novo Nordisk Investigational Site
city: Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Kashiwara-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Kobe, Hyogo
country: Japan
facility: Novo Nordisk Investigational Site
city: Kumamoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Miyazaki
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Shimotsuke-shi, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Suita-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Toyama-shi, Toyama
country: Japan
facility: Novo Nordisk Investigational Site
city: Yamato-shi, Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Yangsan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Davies M, Faerch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021 Mar 13;397(10278):971-984. doi: 10.1016/S0140-6736(21)00213-0. Epub 2021 Mar 2.
citation: Kadowaki T, Isendahl J, Khalid U, Lee SY, Nishida T, Ogawa W, Tobe K, Yamauchi T, Lim S; STEP 6 investigators. Semaglutide once a week in adults with overweight or obesity, with or without type 2 diabetes in an east Asian population (STEP 6): a randomised, double-blind, double-dummy, placebo-controlled, phase 3a trial. Lancet Diabetes Endocrinol. 2022 Mar;10(3):193-206. doi: 10.1016/S2213-8587(22)00008-0. Epub 2022 Feb 4.