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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05035095

Collaborator

(none)

660

Enrollment

Locations

Arms

Anticipated Duration (Months)

12.9

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight	Drug: Oral semaglutide Drug: Placebo (semaglutide)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

660 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 :

Sep 13, 2021

Anticipated Primary Completion Date :

Mar 27, 2023

Anticipated Study Completion Date :

May 15, 2023

Arms and Interventions

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.

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Birmingham	Alabama	United States	35233
2	Novo Nordisk Investigational Site	Los Angeles	California	United States	90057
3	Novo Nordisk Investigational Site	Plantation	Florida	United States	33324
4	Novo Nordisk Investigational Site	Honolulu	Hawaii	United States	96814
5	Novo Nordisk Investigational Site	Indianapolis	Indiana	United States	46260
6	Novo Nordisk Investigational Site	Wilmington	North Carolina	United States	28401
7	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19104-3317
8	Novo Nordisk Investigational Site	Dallas	Texas	United States	75230
9	Novo Nordisk Investigational Site	Arlington	Virginia	United States	22206
10	Novo Nordisk Investigational Site	Winchester	Virginia	United States	22601-3834
11	Novo Nordisk Investigational Site	Olympia	Washington	United States	98502
12	Novo Nordisk Investigational Site	Surrey	British Columbia	Canada	V3Z 2N6
13	Novo Nordisk Investigational Site	Moncton	New Brunswick	Canada	E1G 1A7
14	Novo Nordisk Investigational Site	Halifax	Nova Scotia	Canada	B3H 1V7
15	Novo Nordisk Investigational Site	Hamilton	Ontario	Canada	L8L 5G8
16	Novo Nordisk Investigational Site	Hamilton	Ontario	Canada	L8M 1K7
17	Novo Nordisk Investigational Site	Hellerup		Denmark	2900
18	Novo Nordisk Investigational Site	Hvidovre		Denmark	2650
19	Novo Nordisk Investigational Site	Køge		Denmark	4600
20	Novo Nordisk Investigational Site	Slagelse		Denmark	4200
21	Novo Nordisk Investigational Site	Jyväskylä		Finland	40620
22	Novo Nordisk Investigational Site	Seinäjoki		Finland	60220
23	Novo Nordisk Investigational Site	University Of Helsinki		Finland	00014
24	Novo Nordisk Investigational Site	Le Coudray		France	28630
25	Novo Nordisk Investigational Site	Le Creusot		France	71200
26	Novo Nordisk Investigational Site	Pessac		France	33600
27	Novo Nordisk Investigational Site	Saint Herblain		France	44800
28	Novo Nordisk Investigational Site	Venissieux		France	69200
29	Novo Nordisk Investigational Site	Essen		Germany	45136
30	Novo Nordisk Investigational Site	Hamburg		Germany	22041
31	Novo Nordisk Investigational Site	Hohenmölsen		Germany	06679
32	Novo Nordisk Investigational Site	Oldenburg I. Holst		Germany	23758
33	Novo Nordisk Investigational Site	Rehlingen-Siersburg		Germany	66780
34	Novo Nordisk Investigational Site	Stuttgart		Germany	70378
35	Novo Nordisk Investigational Site	Wangen		Germany	88239
36	Novo Nordisk Investigational Site	Chiba-shi, Chiba		Japan	260-8677
37	Novo Nordisk Investigational Site	Chiyoda-ku, Tokyo		Japan	101-0065
38	Novo Nordisk Investigational Site	Tokyo		Japan	169-0072
39	Novo Nordisk Investigational Site	Bialystok		Poland	15-281
40	Novo Nordisk Investigational Site	Gdynia		Poland	81-338
41	Novo Nordisk Investigational Site	Lodz		Poland	90-242
42	Novo Nordisk Investigational Site	Lublin		Poland	20-538
43	Novo Nordisk Investigational Site	Poznan		Poland	60-589
44	Novo Nordisk Investigational Site	Dzerzhinskiy		Russian Federation	140091
45	Novo Nordisk Investigational Site	Ekaterinburg		Russian Federation	620075
46	Novo Nordisk Investigational Site	Moscow		Russian Federation	117292
47	Novo Nordisk Investigational Site	Moscow		Russian Federation	119034
48	Novo Nordisk Investigational Site	Moscow		Russian Federation	127486
49	Novo Nordisk Investigational Site	Saint Petersburg		Russian Federation	190013
50	Novo Nordisk Investigational Site	Saint Petersburg		Russian Federation	194291
51	Novo Nordisk Investigational Site	Tumen		Russian Federation	625023

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT05035095

Other Study ID Numbers:

NN9932-4737
U1111-1253-1670
2020-002953-11

First Posted:

Sep 5, 2021

Last Update Posted:

Jan 27, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Overweight

Study Results

No Results Posted as of Jan 27, 2022