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

Last updated: November 18, 2021
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT03548935
NN9536-4373
U1111-1200-8053
2017-003436-36
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Main phase:

  • Male or female, age greater than or equal to 18 years at the time of signing informedconsent
  • 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-relatedcomorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleepapnoea 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 activitiesfor the extension phase
  • On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mgsemaglutide once-weekly or semaglutide placebo

Exclusion

Exclusion Criteria: Main phase:

  • Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measuredby the central laboratory at screening
  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days beforescreening irrespective of medical records Extension phase:
  • Female who is pregnant or intends to become pregnant during the extension phase
  • Any disorder, unwillingness or inability, not covered by any of the other exclusioncriteria, which in the investigator's opinion, might jeopardise the subject'scompliance with the extension of the trial

Study Design

Total Participants: 1961
Study Start date:
June 04, 2018
Estimated Completion Date:
March 05, 2021

Connect with a study center

  • Novo Nordisk Investigational Site

    Caba, C1093AAS
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Ciudad de Buenos Aires, C1204AAD
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Corrientes, 3400
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Córdoba, X5006IKK
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Santa Rosa, 6300
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Boussu, 7300
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Edegem, 2650
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Liège, 4000
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Sofia, 1606
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Edmonton, Alberta T6H 2L4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Surrey, British Columbia V3Z 2N6
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    North York, Ontario M2M 4J5
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Toronto, Ontario M4P 1P2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    PQ, Quebec G1L 3L5
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Quebec, G1V 4G2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Oulu, 90220
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    University Of Helsinki, 00014
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Le Coudray, 28630
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Narbonne, 11108
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    PARIS cedex 13, 75651
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Paris, 75908
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Pessac, 33600
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Pierre Benite, 69310
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Poitiers, 86000
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Venissieux, 69200
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Berlin, 12627
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Bochum, 44787
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Essen, 45219
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Falkensee, 14612
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Frankfurt, 60313
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Giessen, 35392
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamburg, 22607
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hohenmölsen, 06679
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Leipzig, 04103
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Ingbert, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Ingbert-Oberwürzbach, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Stuttgart, 70378
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Wangen, 88239
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Guntur, Andhra Pradesh 522001
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Secunderabad,, Andhra Pradesh 500003
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Surat, Gujarat 395002
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Rohtak, Haryana 124001
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kozhikode, Kerala 673017
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Thiruvananthapuram, Kerala 695031
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Nagpur, Maharashtra 440003
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Pune, Maharashtra 411004
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    New Dehli, New Delhi 110029
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu 600116
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal 700054
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Hyderabad, 500 012
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Ludhiana, 141001
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Chiba-shi, Chiba, 260-8677
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Chuo-ku, Tokyo, 103 0027
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Shinjuku-ku, Tokyo, 160-0008
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Suita-shi, Osaka, 565-0853
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Tokyo, 103-0027
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Hermosillo, Sonora 83280
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Merida, Yucatan 97070
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Gdynia, 81-338
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Lodz, 90-242
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Poznan, 60-589
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Szczecin, 70-376
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Novo Nordisk Investigational Site

    Moscow, 117036
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Novosibirsk, 630099
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Penza, 440026
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint-Petersburg, 194358
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Tomsk, 634041
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Voronezh, 394018
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Taipei, 100
    Taiwan

    Site Not Available

  • Novo Nordisk Investigational Site

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Coventry, CV2 2DX
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Glasgow, G31 2ER
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Liverpool, L9 7AL
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Norwich, NR4 7UQ
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Rotherham, S65 1DA
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Taunton, TA1 5DA
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Anaheim, California 92801
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lomita, California 90717
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Spring Valley, California 91978
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chiefland, Florida 32626
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Crystal River, Florida 34429
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32205
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ocala, Florida 34470
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Panama City, Florida 32401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Plantation, Florida 33324
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ponte Vedra, Florida 32081
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Buckley, Michigan 49620
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Butte, Montana 59701
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Omaha, Nebraska 68105
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rochester, New York 14609
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Simpsonville, South Carolina 29681
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashville, Tennessee 37212-1150
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Austin, Texas 78749
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75230
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Renton, Washington 98057
    United States

    Site Not Available

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