STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Launched by NOVO NORDISK A/S · May 25, 2018
Trial Information
Current as of May 09, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- 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
- • Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's compliance with the extension of the trial
About Novo Nordisk A/S
Novo Nordisk A/S is a global healthcare company headquartered in Denmark, specializing in the research, development, manufacturing, and marketing of innovative pharmaceuticals, particularly in the fields of diabetes care, obesity treatment, and hormone replacement therapies. With a strong commitment to improving patient outcomes, Novo Nordisk invests significantly in clinical trials to advance scientific knowledge and develop effective therapies. The company is dedicated to sustainability and ethical practices, striving to deliver high-quality healthcare solutions while addressing the evolving needs of patients worldwide. Through collaboration and innovation, Novo Nordisk aims to lead the way in transforming diabetes and other chronic diseases into manageable conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charleston, South Carolina, United States
Anaheim, California, United States
Chicago, Illinois, United States
Topeka, Kansas, United States
Hamburg, , Germany
Bristol, , United Kingdom
Spring Valley, California, United States
Narbonne, , France
Venissieux, , France
Renton, Washington, United States
Chiefland, Florida, United States
Plantation, Florida, United States
West Reading, Pennsylvania, United States
Aurora, Colorado, United States
Richmond, Virginia, United States
Indianapolis, Indiana, United States
New Dehli, New Delhi, India
Leipzig, , Germany
Taipei, , Taiwan
Pessac, , France
Caba, , Argentina
Corrientes, , Argentina
Liège, , Belgium
Sofia, , Bulgaria
Moscow, , Russian Federation
Liverpool, , United Kingdom
Coventry, , United Kingdom
Plovdiv, , Bulgaria
Bruxelles, , Belgium
Leuven, , Belgium
London, , United Kingdom
Edegem, , Belgium
Jacksonville, Florida, United States
Butte, Montana, United States
Waterbury, Connecticut, United States
Hohenmölsen, , Germany
Quebec, , Canada
Wangen, , Germany
Louisville, Kentucky, United States
Rochester, New York, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
San Juan, , Puerto Rico
Panama City, Florida, United States
Roswell, Georgia, United States
Oulu, , Finland
Aarhus N, , Denmark
Falkensee, , Germany
Simpsonville, South Carolina, United States
Kolkata, West Bengal, India
Crystal River, Florida, United States
Round Rock, Texas, United States
Hamilton, Ontario, Canada
Giessen, , Germany
Ponte Vedra, Florida, United States
Buckley, Michigan, United States
Yaroslavl, , Russian Federation
Szczecin, , Poland
Penza, , Russian Federation
Voronezh, , Russian Federation
Toronto, Ontario, Canada
Córdoba, , Argentina
Omaha, Nebraska, United States
Saint Ingbert Oberwürzbach, , Germany
Glasgow, , United Kingdom
Saint Petersburg, , Russian Federation
Boussu, , Belgium
University Of Helsinki, , Finland
Paris Cedex 13, , France
Stuttgart, , Germany
Cambridge, , United Kingdom
Lodz, , Poland
Guntur, Andhra Pradesh, India
Rohtak, Haryana, India
Ciudad De Buenos Aires, , Argentina
Lomita, California, United States
Ocala, Florida, United States
Guadalajara, Jalisco, Mexico
Pune, Maharashtra, India
Suita Shi, Osaka, , Japan
Anniston, Alabama, United States
Essen, , Germany
Chennai, Tamil Nadu, India
Tokyo, , Japan
Novosibirsk, , Russian Federation
Tomsk, , Russian Federation
Austin, Texas, United States
Ludhiana, , India
Poznan, , Poland
Taunton, , United Kingdom
Chiba Shi, Chiba, , Japan
Surat, Gujarat, India
Bountiful, Utah, United States
Le Coudray, , France
Dallas, Texas, United States
Hyderabad, , India
Edmonton, Alberta, Canada
Thiruvananthapuram, Kerala, India
Merida, Yucatan, Mexico
Surrey, British Columbia, Canada
Nagpur, Maharashtra, India
Rotherham, , United Kingdom
Paris, , France
Norwich, , United Kingdom
Saint Peters, Missouri, United States
Nashville, Tennessee, United States
Santa Rosa, , Argentina
North York, Ontario, Canada
Pierre Benite, , France
Berlin, , Germany
Bochum, , Germany
Frankfurt, , Germany
Secunderabad,, Andhra Pradesh, India
Hermosillo, Sonora, Mexico
Gdynia, , Poland
Patients applied
Trial Officials
Clinical Reporting Anchor and Disclosure (1452)
Study Director
Novo Nordisk A/S
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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