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STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

NCT ID: NCT03548935

Last Updated: 2021-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1961 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2021-03-05

Brief Summary

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This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants 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 you can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get, 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 has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.

Detailed Description

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Conditions

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Metabolism and Nutrition Disorder Overweight or Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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Semaglutide s.c. 2.4 mg once weekly

Participants will receive semaglutide for 68 weeks.

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks. Dose escalation of semaglutide will take place as follows: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 68.

Semaglutide placebo

Participants will receive semaglutide matching placebo for 68 weeks.

Group Type PLACEBO_COMPARATOR

Placebo (semaglutide)

Intervention Type DRUG

Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks.

Interventions

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Semaglutide

Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks. Dose escalation of semaglutide will take place as follows: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 68.

Intervention Type DRUG

Placebo (semaglutide)

Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Main phase:

* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Body mass index (BMI) greater than or equal to 30.0 kg/sqm or greater than or equal to 27.0 kg/sqm 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

Extension phase:

* Informed consent for the extension phase obtained before any trial related activities for the extension phase
* On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo

Exclusion Criteria

Main phase:

* Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Extension phase:

* Female who is pregnant or intends to become pregnant during the extension phase
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Anniston, Alabama, United States

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Anaheim, California, United States

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Lomita, California, United States

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Spring Valley, California, United States

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Aurora, Colorado, United States

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Waterbury, Connecticut, United States

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Chiefland, Florida, United States

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Crystal River, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Ocala, Florida, United States

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Panama City, Florida, United States

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Plantation, Florida, United States

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Ponte Vedra, Florida, United States

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Roswell, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Topeka, Kansas, United States

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Louisville, Kentucky, United States

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Buckley, Michigan, United States

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City of Saint Peters, Missouri, United States

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Butte, Montana, United States

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Omaha, Nebraska, United States

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Rochester, New York, United States

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Salisbury, North Carolina, United States

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Wilmington, North Carolina, United States

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West Reading, Pennsylvania, United States

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Charleston, South Carolina, United States

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Simpsonville, South Carolina, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Round Rock, Texas, United States

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Bountiful, Utah, United States

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Richmond, Virginia, United States

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Renton, Washington, United States

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CABA, , Argentina

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Ciudad de Buenos Aires, , Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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Santa Rosa, , Argentina

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Boussu, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Edmonton, Alberta, Canada

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Surrey, British Columbia, Canada

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Hamilton, Ontario, Canada

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North York, Ontario, Canada

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Toronto, Ontario, Canada

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Québec, , Canada

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Québec, , Canada

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Aarhus N, , Denmark

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Oulu, , Finland

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University of Helsinki, , Finland

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Le Coudray, , France

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Narbonne, , France

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Paris, , France

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Paris, , France

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Pessac, , France

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Pierre-Bénite, , France

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Vénissieux, , France

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Berlin, , Germany

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Bochum, , Germany

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Essen, , Germany

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Essen, , Germany

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Falkensee, , Germany

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Frankfurt, , Germany

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Giessen, , Germany

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Hamburg, , Germany

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Hohenmölsen, , Germany

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Leipzig, , Germany

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Saint Ingbert-Oberwürzbach, , Germany

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Stuttgart, , Germany

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Wangen, , Germany

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Guntur, Andhra Pradesh, India

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Secunderabad,, Andhra Pradesh, India

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Surat, Gujarat, India

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Rohtak, Haryana, India

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Thiruvananthapuram, Kerala, India

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Nagpur, Maharashtra, India

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Pune, Maharashtra, India

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Pune, Maharashtra, India

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New Dehli, New Delhi, India

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Chennai, Tamil Nadu, India

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Kolkata, West Bengal, India

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Hyderabad, , India

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Ludhiana, , India

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Chiba-shi, Chiba, , Japan

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Suita-shi, Osaka, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Guadalajara, Jalisco, Mexico

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Hermosillo, Sonora, Mexico

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Mérida, Yucatán, Mexico

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Gdynia, , Poland

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Lodz, , Poland

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Poznan, , Poland

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Szczecin, , Poland

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San Juan, , Puerto Rico

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Moscow, , Russia

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Novosibirsk, , Russia

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Novosibirsk, , Russia

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Penza, , Russia

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Saint Petersburg, , Russia

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Tomsk, , Russia

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Voronezh, , Russia

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Yaroslavl, , Russia

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Taipei, , Taiwan

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Bristol, , United Kingdom

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Cambridge, , United Kingdom

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Coventry, , United Kingdom

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Glasgow, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Norwich, , United Kingdom

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Rotherham, , United Kingdom

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Taunton, , United Kingdom

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Countries

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United States Argentina Belgium Bulgaria Canada Denmark Finland France Germany India Japan Mexico Poland Puerto Rico Russia Taiwan United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 32441473 (View on PubMed)

Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.

Reference Type RESULT
PMID: 33567185 (View on PubMed)

Schattenberg JM, Gronbaek H, Kliers I, Ladelund S, Long MT, Nygard SB, Sanyal AJ, Davies MJ. Proteomic signatures reflect effects of semaglutide treatment for MASH. JHEP Rep. 2025 Jul 22;7(10):101521. doi: 10.1016/j.jhepr.2025.101521. eCollection 2025 Oct.

Reference Type DERIVED
PMID: 40980163 (View on PubMed)

Kral P, Holst-Hansen T, Olivieri AV, Ivanescu C, Lamotte M, Larsen S. The Correlation Between Body Mass Index and Health-Related Quality of Life: Data from Two Weight Loss Intervention Studies. Adv Ther. 2024 Nov;41(11):4228-4247. doi: 10.1007/s12325-024-02932-8. Epub 2024 Sep 24.

Reference Type DERIVED
PMID: 39316288 (View on PubMed)

Wadden TA, Brown GK, Egebjerg C, Frenkel O, Goldman B, Kushner RF, McGowan B, Overvad M, Fink-Jensen A. Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials. JAMA Intern Med. 2024 Nov 1;184(11):1290-1300. doi: 10.1001/jamainternmed.2024.4346.

Reference Type DERIVED
PMID: 39226070 (View on PubMed)

McGowan BM, Houshmand-Oeregaard A, Laursen PN, Zeuthen N, Baker-Knight J. Impact of BMI and comorbidities on efficacy of once-weekly semaglutide: Post hoc analyses of the STEP 1 randomized trial. Obesity (Silver Spring). 2023 Apr;31(4):990-999. doi: 10.1002/oby.23732. Epub 2023 Mar 6.

Reference Type DERIVED
PMID: 36876594 (View on PubMed)

Heerspink HJL, Apperloo E, Davies M, Dicker D, Kandler K, Rosenstock J, Sorrig R, Lawson J, Zeuthen N, Cherney D. Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials. Diabetes Care. 2023 Apr 1;46(4):801-810. doi: 10.2337/dc22-1889.

Reference Type DERIVED
PMID: 36801984 (View on PubMed)

Kosiborod MN, Bhatta M, Davies M, Deanfield JE, Garvey WT, Khalid U, Kushner R, Rubino DM, Zeuthen N, Verma S. Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. Diabetes Obes Metab. 2023 Feb;25(2):468-478. doi: 10.1111/dom.14890. Epub 2022 Oct 28.

Reference Type DERIVED
PMID: 36200477 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35724304 (View on PubMed)

Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, Lingvay I, McGowan BM, Oral TK, Rosenstock J, Wadden TA, Wharton S, Yokote K, Kushner RF; STEP 1 Study Group. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564. doi: 10.1111/dom.14725. Epub 2022 May 19.

Reference Type DERIVED
PMID: 35441470 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30122305 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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U1111-1200-8053

Identifier Type: OTHER

Identifier Source: secondary_id

2017-003436-36

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9536-4373

Identifier Type: -

Identifier Source: org_study_id