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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)

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oral semaglutide
Placebo (semaglutide)
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral semaglutide

Oral semaglutide placebo

Arm Description

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)

All participants are given once daily dose for 68 weeks

Outcomes

Primary Outcome Measures

Relative change in body weight
percentage-point
Achievement of body weight reduction greater than or equal to 5% (Yes/No)
Count of participants

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2021
Last Updated
June 8, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05035095
Brief Title
Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)
Acronym
OASIS 1
Official Title
Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
March 24, 2023 (Actual)
Study Completion Date
May 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
667 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral semaglutide
Arm Type
Experimental
Arm Description
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)
Arm Title
Oral semaglutide placebo
Arm Type
Placebo Comparator
Arm Description
All participants are given once daily dose for 68 weeks
Intervention Type
Drug
Intervention Name(s)
Oral semaglutide
Intervention Description
Participants will receive a daily dose of oral semaglutide.
Intervention Type
Drug
Intervention Name(s)
Placebo (semaglutide)
Intervention Description
Oral placebo (semaglutide) once daily. Planned treatment duration will be 68 weeks.
Primary Outcome Measure Information:
Title
Relative change in body weight
Description
percentage-point
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Achievement of body weight reduction greater than or equal to 5% (Yes/No)
Description
Count of participants
Time Frame
At end-of-treatment (week 68)
Secondary Outcome Measure Information:
Title
Achievement of body weight reduction greater than or equal to 10% (Yes/No)
Description
Count of participants
Time Frame
At end of treatment (week 68)
Title
Change in Short Form-36 (SF-36) Physical Function
Description
Score points
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in IWQOL-Lite-CT Physical Function
Description
Score points
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in waist circumference
Description
measured in cm
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Achievement of body weight reduction greater than or equal to 15% (Yes/No)
Description
Count of participants
Time Frame
At end of treatment (week 68)
Title
Achievement of body weight reduction greater than or equal to 20% (Yes/No)
Description
Count of participants
Time Frame
At end of treatment (week 68)
Title
Change in body mass index (BMI)
Description
measured in kg/m^2
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in systolic blood pressure
Description
measured in mmHg
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in diastolic blood pressure
Description
measured in mmHg
Time Frame
From randomisation (week 0) to end of treatment (week 68)
Title
Change in HbA1c (glycated haemoglobin)
Description
percentage-point
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in fasting plasma glucose (FPG)
Description
measured in mg/dL
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in fasting serum insulin
Description
Ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in lipids: Total cholesterol
Description
Ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in lipids: HDL (high density lipoprotein) cholesterol
Description
Ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in lipids: LDL (low-density lipoprotein) cholesterol
Description
Ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in lipids: VLDL (very-low density lipoprotein) cholesterol
Description
Ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in lipids: Triglycerides
Description
Ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in lipids: Free fatty acids
Description
Ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in high sensitivity C-Reactive Protein
Description
Ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Number of treatment emergent adverse events
Description
Count of events
Time Frame
From baseline (week 0) to end-of-trial (week 75)
Title
Number of serious adverse events
Description
Count of events
Time Frame
From baseline (week 0) to end-of-trial (week 75)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-3317
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22206
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601-3834
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3Z 2N6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Seinäjoki
ZIP/Postal Code
60220
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
University Of Helsinki
ZIP/Postal Code
00014
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Le Coudray
ZIP/Postal Code
28630
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Le Creusot
ZIP/Postal Code
71200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
22041
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hohenmölsen
ZIP/Postal Code
06679
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Oldenburg I. Holst
ZIP/Postal Code
23758
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rehlingen-Siersburg
ZIP/Postal Code
66780
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Stuttgart
ZIP/Postal Code
70378
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Chiba-shi, Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Chiyoda-ku, Tokyo
ZIP/Postal Code
101-0065
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
169-0072
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Lublin
State/Province
Lubelski
ZIP/Postal Code
20-538
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
State/Province
Podlaskie Voivodeship
ZIP/Postal Code
15-281
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Poznan
State/Province
Wielkopolskie Voivodeship
ZIP/Postal Code
60-589
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lodz
ZIP/Postal Code
90-338
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Tumen
State/Province
Russia
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Dzerzhinskiy
ZIP/Postal Code
140091
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620075
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
119034
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
127486
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint Petersburg
ZIP/Postal Code
190013
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

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

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