Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity.
STEP7
Effect and Safety of Semaglutide 2.4 mg Once-weekly on Weight Management in Subjects With Overweight or Obesity.
2 other identifiers
interventional
375
4 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2020
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2020
CompletedFirst Posted
Study publicly available on registry
January 31, 2020
CompletedStudy Start
First participant enrolled
December 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2022
CompletedResults Posted
Study results publicly available
November 29, 2024
CompletedJanuary 29, 2026
December 1, 2025
1.7 years
January 30, 2020
August 21, 2023
January 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Body Weight (Percentage [%])
Change from baseline at week 0 to week 44 in body weight (%) is presented.The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization (week 0) to last trial-related participant-site contact (week 51).
Baseline (week 0), week 44
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No)
Number of participants who achieved \>=5% weight reduction at week 44 for in-trial observation period is presented.In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction. In-trial observation period: the uninterrupted time interval from the start of randomization (week 0) to last trial-related participant-site contact (week 51).
At week 44
Secondary Outcomes (41)
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 10% (Yes/No)
At week 44
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 15% (Yes/No)
At week 44
Change From Baseline in Waist Circumference
Baseline (week 0), week 44
Change From Baseline in Body Weight (Kilogram [kg])
Baseline (week 0), week 44
Change From Baseline in Body Mass Index (BMI)
Baseline (week 0), week 44
- +36 more secondary outcomes
Study Arms (2)
Semaglutide
EXPERIMENTALOnce-weekly injections of gradually increased doses of semaglutide
Placebo (semaglutide)
PLACEBO COMPARATOROnce-weekly injections of gradually increased doses of semaglutide placebo
Interventions
Semaglutide placebo administered s.c. as an adjunct to a reduced-calorie diet and increased physical activity regimen for 44 weeks
Semaglutide administered subcutaneously (s.c., under the skin) as well as diet and physical activity counselling for 44 weeks. Doses gradually increased to 2.4 mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (33)
Instituto de Ciências Farmacêuticas de Estudos e Pesquisas
Aparecida de Goiânia, Goiás, 74935-530, Brazil
CPCLIN - Centro de Pesquisas Clínicas
São Paulo, São Paulo, 01228-200, Brazil
The First Affiliated Hospital of Anhui Medical University-Endocrinology
Hefei, Anhui, 230061, China
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing, Beijing Municipality, 100853, China
Beijing Luhe Hospital Capital Medical University
Beijing, Beijing Municipality, 101100, China
Beijing Pinggu Hospital-Endocrinology
Beijing, Beijing Municipality, 101200, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404000, China
Fujian Medical University Union Hospital-Endocrinology
Fuzhou, Fujian, 350001, China
Cangzhou People's Hospital-Endocrinology
Cangzhou, Hebei, 061000, China
Cangzhou People's Hospital
Cangzhou, Hebei, 061000, China
Harrison International Peace Hospital-Endocrinology
Hengshui, Hebei, 053000, China
Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
Hengshui, Hebei, 053000, China
The Second Hospital of Hebei Medical University-Endocrinology
Shijiazhuang, Hebei, 050000, China
Inner Mongolia People's Hospital-Endocrinology
Hohhot, Inner Mongolia, 010020, China
The affiliated Hospital of Inner Mongolia Medical University-Endocrinology
Hohhot, Inner Mongolia, 010050, China
Changzhou No.2 People's Hospital, Yanghu Branch
Changzhou, Jiangsu, 213003, China
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu, 210011, China
Jiangsu Province Hospital-Endocrinology
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, 212001, China
The First Bethune hospital of Jilin University-Endocrinology
Changchun, Jilin, 130061, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Huashan Hospital Fudan University-Endocrinology
Shanghai, Shanghai Municipality, 200040, China
Shanghai Tenth People's Hospital (Tenth People's of Tongji University)-Endocrinology
Shanghai, Shanghai Municipality, 200072, China
Shanghai Fifth People's Hospital-Endocrinology
Shanghai, Shanghai Municipality, 200240, China
Tongren Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200336, China
Shanghai Pudong New Area People's Hospital-Endocrinology
Shanghai, Shanghai Municipality, 201200, China
General Hospital of Tianjin Medical University-Endocrinology
Tianjin, Tianjin Municipality, 300052, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650101, China
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Ajou University Hospital
Gyeonggi-do, 16499, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Related Publications (1)
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.
PMID: 38330988RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Reporting Office (2834)
- Organization
- Novo Nordisk A/S
Study Officials
- STUDY DIRECTOR
Clinical Reporting Anchor & Disclosure (1452)
Novo Nordisk A/S
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2020
First Posted
January 31, 2020
Study Start
December 8, 2020
Primary Completion
August 23, 2022
Study Completion
August 23, 2022
Last Updated
January 29, 2026
Results First Posted
November 29, 2024
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com