Clinical trial NCT04251156: Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity.
Official title: Effect and Safety of Semaglutide 2.4 mg Once-weekly on Weight Management in Subjects With Overweight or Obesity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Obesity
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-01-31
Enrollment: 375
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 body weight from the start to the end of the study. The purpose of the study 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 else they can do to lose weight. Participants will either get semaglutide or "dummy medicine" - which treatment 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 skinfold in the stomach, thigh or upper arm.• The study will last for about 1 year. Participants will have 11 clinic visits and 8 phone calls with the study doctor. Participants will have 3 clinic visits where they cannot eat and drink (water is allowed) for up to 8 hours before the visit and 1 clinic visit where they cannot eat and drink for up to 2 hours before the visit. (4 visits and 1 visit, respectively, if they have type 2 diabetes (T2D)). Participants will have 4 clinic visits where they will have blood samples taken. (5 visits if they have T2D). For China: Participants will have 9 clinic visits where they will have blood samples taken. 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
* History of at least one self-reported unsuccessful dietary effort to lose body weight

For subjects without T2D at screening:

* Body mass index (BMI) of :
* greater than or equal to 30 kg/m\^2
* greater 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

For subjects with T2D at screening:

* Diagnosed with T2D above or equal to 180 days prior to the day of screening
* Treated with either:
* diet and exercise alone or
* stable treatment (same drug(s), dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic medications alone or in any combination (metformin, α-glucosidase inhibitor (AGI), SU, glinides, SGLT2i or glitazone) according to local label
* HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
* BMI greater than or equal to 27 kg/m\^2

Exclusion Criteria:

* A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records

For subjects without T2D at screening:

- HbA1c equal to or above 6.5% (48 mmol/mol) as measured by the central laboratory at screening

For subjects with T2D at screening :

* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 mL/min/1.73 m\^2 (below 60 mL/min/1.73 m\^2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 2012 by the central laboratory at screening
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Primary outcomes:
measure: Change From Baseline in Body Weight (Percentage [%])
timeFrame: Baseline (week 0), week 44
measure: Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No)
timeFrame: At week 44
Secondary outcomes:
measure: Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 10% (Yes/No)
timeFrame: At week 44
measure: Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 15% (Yes/No)
timeFrame: At week 44
measure: Change From Baseline in Waist Circumference
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Body Weight (Kilogram [kg])
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline (week 0), week 44
measure: Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 20% (Yes/No)
timeFrame: At week 44
measure: Change From Baseline in Systolic Blood Pressure
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Short Form-36 (SF-36) - Physical Functioning Score
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT) - Physical Function Domain (5-items) Score
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%])
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol])
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Fasting Plasma Glucose (FPG) (Milligrams Per Deciliter [mg/dL])
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in FPG (Millimoles Per Liter [mmol/L])
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Fasting Serum Insulin: Ratio to Baseline
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Diastolic Blood Pressure
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Total Cholesterol: Ratio to Baseline
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in High-Density Lipoproteins (HDL)-Ratio to Baseline
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Low-Density Lipoproteins (LDL)-Ratio to Baseline
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Very Low-Density Lipoproteins (VLDL)-Ratio to Baseline
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Free Fatty Acids-Ratio to Baseline
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Triglycerides-Ratio to Baseline
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in SF-36 All Domains (Except Physical Functioning) and 2 Component Summary Scores
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in IWQOL-Lite for Physical Domain Score, Psychological Domain Score and Total Score
timeFrame: Baseline (week 0), week 44
measure: Number of Participants Who Achieved Responder Definition Value for SF-36 Physical Functioning Score (Yes/No)
timeFrame: At week 44
measure: Number of Participants Who Achieved Responder Definition Value For IWQoL-Lite for CT Physical Function (5-items) Score (Yes/No)
timeFrame: At week 44
measure: Number of Participants With Type 2 Diabetes (T2D) Who Achieved HbA1c Less Than (<) 7.0 Percent (%) (53 mmol/Mol)
timeFrame: At week 44
measure: Number of Participants With T2D Who Achieved HbA1c Less Than or Equal to (<=) 6.5% (48 mmol/Mol)
timeFrame: At week 44
measure: Change From Baseline in Glycaemic Category (Normo-Glycaemia, Pre-Diabetes, T2D) in Participants With no T2D at Baseline
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Number of Participants With Antihypertensive Medication (Decrease, No Change, Increase)
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Number of Participants With Lipid-Lowering Medication (Decrease, No Change, Increase)
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Number of Participants With Concomitant Oral Antidiabetic Medication (Decrease, No Change, Increase) in Participants With No T2D at Baseline
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Number of Participants in Fatty Liver Index (FLI) Score Category
timeFrame: Baseline (week 0), week 44
measure: Number of Participants Who From Randomization Permanently Discontinued Randomized Trial Product
timeFrame: Baseline (week 0), week 44
measure: Time to Permanent Discontinuation of Randomized Trial Product (Weeks)
timeFrame: Baseline (week 0), week 44
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline (week 0), week 51
measure: Number of Serious Adverse Events (SAEs)
timeFrame: Baseline (week 0), week 51
measure: Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes (Yes/No) in Participants With T2D at Week 0
timeFrame: Baseline (week 0), week 51
measure: Change From Baseline in Pulse
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Amylase: Ratio to Baseline
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Lipase: Ratio to Baseline
timeFrame: Baseline (week 0), week 44
measure: Change From Baseline in Calcitonin: Ratio to Baseline
timeFrame: Baseline (week 0), week 44
Other outcomes:
Locations:
city: Aparecida de Goiania
country: Brazil
facility: Instituto de Ciências Farmacêuticas de Estudos e Pesquisas
state: Goias
city: São Paulo
country: Brazil
facility: CPCLIN - Centro de Pesquisas Clínicas
state: Sao Paulo
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Pinggu Hospital
state: Beijing
city: ChongQing
country: China
facility: Chongqing University Three Gorges Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Cangzhou
country: China
facility: Cangzhou People's Hospital
state: Hebei
city: Hengshui
country: China
facility: Harrison International Peace Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Huhehaote
country: China
facility: Inner Mongolia People's Hospital
state: Inner Mongolia
city: Huhhot
country: China
facility: The affiliated hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital, Yanghu Branch
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University_Nanjing
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Zhenjiang
country: China
facility: The Affiliated Hospital of Jiangsu University_Zhenjiang
state: Jiangsu
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
city: Ji'nan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Huashan Hospital, Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People's Hsopital, Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Fifth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong New Area People's Hospital
state: Shanghai
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Shatin, New Territories
country: Hong Kong
facility: Prince of Wales Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor & Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Mu Y, Bao X, Eliaschewitz FG, Hansen MR, Kim BT, Koroleva A, Ma RCW, Yang T, Zu N, Liu M; STEP 7 Study Group. Efficacy and safety of once weekly semaglutide 2.4 mg for weight management in a predominantly east Asian population with overweight or obesity (STEP 7): a double-blind, multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2024 Mar;12(3):184-195. doi: 10.1016/S2213-8587(23)00388-1. Epub 2024 Feb 5.