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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)

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ClinicalTrials.gov Identifier: NCT05035095
Recruitment Status : Completed
First Posted : September 5, 2021
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity Overweight Drug: Oral semaglutide Drug: Placebo (semaglutide) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 667 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)
Actual Study Start Date : September 13, 2021
Actual Primary Completion Date : March 24, 2023
Actual Study Completion Date : May 12, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    percentage-point

  2. Achievement of body weight reduction greater than or equal to 5% (Yes/No) [ Time Frame: At end-of-treatment (week 68) ]
    Count of participants


Secondary Outcome Measures :
  1. Achievement of body weight reduction greater than or equal to 10% (Yes/No) [ Time Frame: At end of treatment (week 68) ]
    Count of participants

  2. Change in Short Form-36 (SF-36) Physical Function [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Score points

  3. Change in IWQOL-Lite-CT Physical Function [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Score points

  4. Change in waist circumference [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    measured in cm

  5. Achievement of body weight reduction greater than or equal to 15% (Yes/No) [ Time Frame: At end of treatment (week 68) ]
    Count of participants

  6. Achievement of body weight reduction greater than or equal to 20% (Yes/No) [ Time Frame: At end of treatment (week 68) ]
    Count of participants

  7. Change in body mass index (BMI) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    measured in kg/m^2

  8. Change in systolic blood pressure [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    measured in mmHg

  9. Change in diastolic blood pressure [ Time Frame: From randomisation (week 0) to end of treatment (week 68) ]
    measured in mmHg

  10. Change in HbA1c (glycated haemoglobin) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    percentage-point

  11. Change in fasting plasma glucose (FPG) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    measured in mg/dL

  12. Change in fasting serum insulin [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Ratio to baseline

  13. Change in lipids: Total cholesterol [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Ratio to baseline

  14. Change in lipids: HDL (high density lipoprotein) cholesterol [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Ratio to baseline

  15. Change in lipids: LDL (low-density lipoprotein) cholesterol [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Ratio to baseline

  16. Change in lipids: VLDL (very-low density lipoprotein) cholesterol [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Ratio to baseline

  17. Change in lipids: Triglycerides [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Ratio to baseline

  18. Change in lipids: Free fatty acids [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Ratio to baseline

  19. Change in high sensitivity C-Reactive Protein [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Ratio to baseline

  20. Number of treatment emergent adverse events [ Time Frame: From baseline (week 0) to end-of-trial (week 75) ]
    Count of events

  21. Number of serious adverse events [ Time Frame: From baseline (week 0) to end-of-trial (week 75) ]
    Count of events


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05035095


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
More Information
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Publications:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT05035095    
Other Study ID Numbers: NN9932-4737
U1111-1253-1670 ( Other Identifier: World Health Organization (WHO) )
2020-002953-11 ( EudraCT Number )
First Posted: September 5, 2021    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
 Semaglutide
Glucagon-Like Peptide-1 Receptor Agonists
Hypoglycemic Agents
Physiological Effects of Drugs