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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name OASIS 1

NCTNCT05035095 (opens ClinicalTrials.gov in a new tab)Other idNN9932-4737Other idU1111-1253-1670Other id2020-002953-11
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
667 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
9 countries

United States, Canada, Denmark, Finland, France, Germany, Japan, Poland, Russia

Start
13 Sept 2021
Primary completion
24 Mar 2023
Completion
12 May 2023
First posted
5 Sept 2021
Last update posted
7 May 2026
Conditions
Obesity · Overweight

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 3

    OASIS 1

    NCT05035095

    13 Sept 2021 to 12 May 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Oral semaglutideDrug
  • Placebo (semaglutide)Drug

Arms2

  • 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)

  • Placebo comparator

    Oral semaglutide placebo

    All participants are given once daily dose for 68 weeks

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percentage Change in Body Weight

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Percentage change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented.

  2. Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 5% (Yes/No)

    Time frame · At end-of-treatment (week 68)

    Registry description

    Number of participants who achieved weight loss greater than or equal to 5% of their baseline body weight (yes/no) at end-of-treatment (week 68) is presented.

Secondary outcomes(20)

  1. Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 10% (Yes/No)

    Time frame · At end-of-treatment (week 68)

    Registry description

    Number of participants who achieved weight loss greater than or equal ≥10% (Yes/No) at end-of-treatment (week 68) is presented.

  2. Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 15% (Yes/No)

    Time frame · At end-of-treatment (week 68)

    Registry description

    Number of participants who achieved weight loss greater than or equal (≥) 15% (Yes/No) at end-of-treatment (week 68) is presented.

  3. Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 20% (Yes/No)

    Time frame · At end-of-treatment (week 68)

    Registry description

    Number of participants who achieved weight loss greater than or equal (≥) 20% (Yes/No) at end-of-treatment (week 68) is presented.

  4. Change in Waist Circumference

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in waist circumference from baseline (week 0) to end-of-treatment (week 68) is presented.

  5. Change in Body Mass Index (BMI)

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in BMI from baseline (week 0) to end-of-treatment (week 68) is presented.

  6. Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.

  7. Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Domain

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in SF-36 v2.0 physical functioning domain from baseline (week 0) to end of treatment (week 68) is presented. The SF-36 form, assesses participants' health-related quality of life (HRQoL) on eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). The scores for SF-36v2 Acute (SF-36) are norm-based scores, i.e., scores transformed to a scale where the 2009 US general population has a mean of 50 (indicates population mean) with a SD of 10. The range of possible scores for the SF-36 Physical Functioning score is 19.03-57.60. Higher scores indicate better physical functioning. A positive change score indicates an improvement since baseline.

  8. Change in Systolic Blood Pressure

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in systolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented.

  9. Change in Diastolic Blood Pressure

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in diastolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented.

  10. Change in Glycosylated Haemoglobin (HbA1c)

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in HbA1c from baseline (week 0) to end-of-treatment (week 68) is presented.

  11. Change in Fasting Plasma Glucose (FPG)

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in FPG from baseline (week 0) to end-of-treatment (week 68) is presented.

  12. Change in Fasting Serum Insulin (Pmol/L) - Ratio to Baseline

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in fasting serum insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to end-of-treatment (week 68) is presented as ratio to baseline.

  13. Change in Total Cholesterol (mg/dL) - Ratio to Baseline

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in total cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.

  14. Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in high density lipoprotein (HDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.

  15. Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in low density lipoprotein (LDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.

  16. Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in very low density lipoprotein (VLDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.

  17. Change in Triglycerides (mg/dL) - Ratio to Baseline

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in triglycerides (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.

  18. Change in Free Fatty Acids (mg/dL) - Ratio to Baseline

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in free fatty acids (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.

  19. Change in High Sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline

    Time frame · Baseline (week 0), end-of-treatment (week 68)

    Registry description

    Change in high sensitivity C-reactive protein (measured in Milligrams per liter (mg/L)) from baseline (week 0) to end-of-treatment (week 68) is presented.

  20. Number of Treatment Emergent Adverse Events

    Time frame · From baseline (week 0) to end-of-study (week 75)

    Registry description

    Number of treatment emergent adverse events from baseline (week 0) to end-of-study (week 75) is presented. An adverse event is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP. Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period. It is the time period in which participant was considered exposed to trial product.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (week 0), end-of-treatment (week 68)

Percentage Change in Body Weight

GroupValue (Percentage (%) change in body weight)Spread
Oral Semaglutide 50 mg-15.810.3
Placebo-2.27.2
Primary outcomeCount of participants· At end-of-treatment (week 68)

Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 5% (Yes/No)

GroupValue (Participants)
Oral Semaglutide 50 mg269
Placebo76
Secondary and other outcome results(6)
Secondary outcomeCount of participants· At end-of-treatment (week 68)

Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 10% (Yes/No)

GroupValue (Participants)
Oral Semaglutide 50 mg220
Placebo35
Secondary outcomeCount of participants· At end-of-treatment (week 68)

Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 15% (Yes/No)

GroupValue (Participants)
Oral Semaglutide 50 mg170
Placebo17
Secondary outcomeCount of participants· At end-of-treatment (week 68)

Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 20% (Yes/No)

GroupValue (Participants)
Oral Semaglutide 50 mg107
Placebo8
Secondary outcomeMean· Baseline (week 0), end-of-treatment (week 68)

Change in Waist Circumference

GroupValue (centimeter (cm))Spread
Oral Semaglutide 50 mg-13.410.0
Placebo-2.87.3
Secondary outcomeMean· Baseline (week 0), end-of-treatment (week 68)

Change in Body Mass Index (BMI)

GroupValue (Kilogram per meter square (kg/m^2))Spread
Oral Semaglutide 50 mg-5.94.0
Placebo-0.92.8
Secondary outcomeMean· Baseline (week 0), end-of-treatment (week 68)

Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function

GroupValue (Score on a scale)Spread
Oral Semaglutide 50 mg14.520.2
Placebo5.019.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oral Semaglutide 50 mgParticipants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).0 / 33432 / 334292 / 334
PlaceboParticipants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.0 / 33329 / 333242 / 333

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

7 results

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.

Knop et al. 2023Lancet (London, England)cited by 315

PMID 37385278DOI 10.1016/s0140-6736(23)01185-6PUB-37385278

Full text at the publisher7 results
Publisher pageSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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