Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1) (OASIS 1)

Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)

This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight.

This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation.

Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes.

Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning

In addition to taking the medicine, participants will have talks with study staff about:

• healthy food choices
• how to be more physically active
• what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits.

Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Oral semaglutide; Drug: Placebo (semaglutide)

• Study Type: Interventional
• Enrollment (Actual): 667
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3Z 2N6
      • Ocean West Research Clinic
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • G.A. Research Associates Ltd.
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Health Authority
  • Ontario
    • Hamilton, Ontario, Canada, L8L 5G8
      • Wharton Med Clin Trials
    • Hamilton, Ontario, Canada, L8M 1K7
      • Hamilton Med Res Group
• Denmark
  • Hellerup, Denmark, 2900
    • Center for Klinisk Metabolisk Forskning
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital Endokrinologisk forsknings afsnit 159
  • Køge, Denmark, 4600
    • Sjællands Universitetshospital
• Finland
  • Helsinki, Finland, 00014
    • Obesity Research Unit
  • Jyväskylä, Finland, 40620
    • StudyCor
  • Seinäjoki, Finland, 60220
    • Seinäjoen keskussairaala
• France
  • Le Coudray, France, 28630
    • Les Hopitaux de Chartres-Hopital Louis Pasteur
  • Le Creusot, France, 71200
    • Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-2
  • Le Creusot, France, 71200
    • Fondation Hôtel-Dieu
  • Pessac, France, 33600
    • Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2
  • Saint Herblain, France, 44800
    • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1
  • Venissieux, France, 69200
    • Groupe Hospitalier Mutualiste Des Portes Du Sud
• Germany
  • Essen, Germany, 45136
    • InnoDiab Forschung GmbH
  • Hamburg, Germany, 22041
    • Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
  • Hohenmölsen, Germany, 06679
    • Milek, Hohenmölsen
  • Oldenburg in Holstein, Germany, 23758
    • RED-Institut für medizinische Forschung und Fortbildung GmbH
  • Rehlingen-Siersburg, Germany, 66780
    • Praxis Dr. med. Wenzl-Bauer
  • Stuttgart, Germany, 70378
    • Erlinger
  • Wangen, Germany, 88239
    • Zentrum für klinische Studien Allgäu Oberschwaben
• Japan
  • Chiba-shi, Chiba, Japan, 260-8677
    • Chiba University Hospital_Diabetes, Metabolism and Endocrinology
  • Chiyoda-ku, Tokyo, Japan, 101-0065
    • Suidoubashi Medical Clinic
  • Tokyo, Japan, 169-0072
    • Higashi-shinjuku clinic
• Poland
  • Lodz, Poland, 90-338
    • Centrum Terapii Wspolczesnej
  • Lubelski
    • Lublin, Lubelski, Poland, 20-538
      • NZOZ Przychodnia Specjalistyczna Medica
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-281
      • Gabinet Leczenia Otylosci i Chorob Dietozaleznych
  • Pomorskie
    • Gdynia, Pomorskie, Poland, 81-338
      • Centrum Medyczne Pratia Gdynia
  • Wielkopolskie Voivodeship
    • Poznan, Wielkopolskie Voivodeship, Poland, 60-589
      • Centrum Zdrowia Metabolicznego
• Russian Federation
  • Dzerzhinskiy, Russian Federation, 140091
    • LLC "Clinic of new technologies in Medicine"
  • Ekaterinburg, Russian Federation, 620075
    • Joint Stock Company "Medical technologies"
  • Moscow, Russian Federation, 117292
    • National Medical Research Center of Endocrinology
  • Moscow, Russian Federation, 127486
    • Federal Bureau for Medical and Social Expertise
  • Moscow, Russian Federation, 119034
    • Endocrinological Dispensary of Department of healthcare ser.
  • Saint Petersburg, Russian Federation, 194291
    • Leningrad Regional Clinical Hospital
  • Saint Petersburg, Russian Federation, 190013
    • Joint Stock Company "Polyclinic Complex"
  • Russia
    • Tumen, Russia, Russian Federation, 625023
      • Tumen State Medical University
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Univ of Alabama Birmingham
  • California
    • Los Angeles, California, United States, 90057
      • Velocity Clin Res Wstlke
  • Florida
    • Plantation, Florida, United States, 33324
      • Clinical Trial Res Assoc,Inc
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East West Med Res Inst
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Midwest Inst For Clin Res
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Accellacare
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-3317
      • The University of Penn Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Res-Dallas
  • Virginia
    • Arlington, Virginia, United States, 22206
      • Washington Cntr Weight Mgmt
    • Winchester, Virginia, United States, 22601-3834
      • Selma Medical Associates
  • Washington
    • Olympia, Washington, United States, 98502
      • Capital Clin Res Ctr,LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 27.0 kg/m^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease OR greater than or equal to 30.0 kg/m^2

• History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

• HbA1c greater than or equal to 6.5% (48 mmol/mol) 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral semaglutide; Participants will receive once daily semaglutide tables in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68)	Drug: Oral semaglutide; Participants will receive a daily dose of oral semaglutide.
Placebo Comparator: Oral semaglutide placebo; All participants are given once daily dose for 68 weeks	Drug: Placebo (semaglutide); Oral placebo (semaglutide) once daily. Planned treatment duration will be 68 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in body weight	percentage-point	From baseline (week 0) to end of treatment (week 68)
Achievement of body weight reduction greater than or equal to 5% (Yes/No)	Count of participants	At end-of-treatment (week 68)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of body weight reduction greater than or equal to 10% (Yes/No)	Count of participants	At end of treatment (week 68)
Change in Short Form-36 (SF-36) Physical Function	Score points	From baseline (week 0) to end of treatment (week 68)
Change in IWQOL-Lite-CT Physical Function	Score points	From baseline (week 0) to end of treatment (week 68)
Change in waist circumference	measured in cm	From baseline (week 0) to end of treatment (week 68)
Achievement of body weight reduction greater than or equal to 15% (Yes/No)	Count of participants	At end of treatment (week 68)
Achievement of body weight reduction greater than or equal to 20% (Yes/No)	Count of participants	At end of treatment (week 68)
Change in body mass index (BMI)	measured in kg/m^2	From baseline (week 0) to end of treatment (week 68)
Change in systolic blood pressure	measured in mmHg	From baseline (week 0) to end of treatment (week 68)
Change in diastolic blood pressure	measured in mmHg	From randomisation (week 0) to end of treatment (week 68)
Change in HbA1c (glycated haemoglobin)	percentage-point	From baseline (week 0) to end of treatment (week 68)
Change in fasting plasma glucose (FPG)	measured in mg/dL	From baseline (week 0) to end of treatment (week 68)
Change in fasting serum insulin	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Change in lipids: Total cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Change in lipids: HDL (high density lipoprotein) cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Change in lipids: LDL (low-density lipoprotein) cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Change in lipids: VLDL (very-low density lipoprotein) cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Change in lipids: Triglycerides	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Change in lipids: Free fatty acids	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Change in high sensitivity C-Reactive Protein	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Number of treatment emergent adverse events	Count of events	From baseline (week 0) to end-of-trial (week 75)
Number of serious adverse events	Count of events	From baseline (week 0) to end-of-trial (week 75)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Publications and helpful links

General Publications

• Knop FK, Aroda VR, do Vale RD, Holst-Hansen T, Laursen PN, Rosenstock J, Rubino DM, Garvey WT; OASIS 1 Investigators. Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Aug 26;402(10403):705-719. doi: 10.1016/S0140-6736(23)01185-6. Epub 2023 Jun 26.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): May 12, 2023

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide-1 Receptor Agonists; Semaglutide
• Other Study ID Numbers: NN9932-4737; U1111-1253-1670 (Other Identifier: World Health Organization (WHO)); 2020-002953-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No