Clinical trial NCT05035095: Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Overweight
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 667
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of body weight reduction greater than or equal to 5% (Yes/No)
timeFrame: At end-of-treatment (week 68)
Secondary outcomes:
measure: Achievement of body weight reduction greater than or equal to 10% (Yes/No)
timeFrame: At end of treatment (week 68)
measure: Change in Short Form-36 (SF-36) Physical Function
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in IWQOL-Lite-CT Physical Function
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of body weight reduction greater than or equal to 15% (Yes/No)
timeFrame: At end of treatment (week 68)
measure: Achievement of body weight reduction greater than or equal to 20% (Yes/No)
timeFrame: At end of treatment (week 68)
measure: Change in body mass index (BMI)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in systolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in diastolic blood pressure
timeFrame: From randomisation (week 0) to end of treatment (week 68)
measure: Change in HbA1c (glycated haemoglobin)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in fasting plasma glucose (FPG)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in fasting serum insulin
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in lipids: Total cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in lipids: HDL (high density lipoprotein) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in lipids: LDL (low-density lipoprotein) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in lipids: VLDL (very-low density lipoprotein) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in lipids: Triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in lipids: Free fatty acids
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in high sensitivity C-Reactive Protein
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Number of treatment emergent adverse events
timeFrame: From baseline (week 0) to end-of-trial (week 75)
measure: Number of serious adverse events
timeFrame: From baseline (week 0) to end-of-trial (week 75)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Velocity Clin Res Wstlke
state: California
city: Plantation
country: United States
facility: Clinical Trial Res Assoc,Inc
state: Florida
city: Honolulu
country: United States
facility: East West Med Res Inst
state: Hawaii
city: Indianapolis
country: United States
facility: Midwest Inst For Clin Res
state: Indiana
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Philadelphia
country: United States
facility: The University of Penn Center
state: Pennsylvania
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Arlington
country: United States
facility: Washington Cntr Weight Mgmt
state: Virginia
city: Winchester
country: United States
facility: Selma Medical Associates
state: Virginia
city: Olympia
country: United States
facility: Capital Clin Res Ctr,LLC
state: Washington
city: Surrey
country: Canada
facility: Ocean West Research Clinic
state: British Columbia
city: Moncton
country: Canada
facility: G.A. Research Associates Ltd.
state: New Brunswick
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: Wharton Med Clin Trials
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Med Res Group
state: Ontario
city: Hellerup
country: Denmark
facility: Center for Klinisk Metabolisk Forskning
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital Endokrinologisk forsknings afsnit 159
city: Køge
country: Denmark
facility: Sjællands Universitetshospital
city: Helsinki
country: Finland
facility: Obesity Research Unit
city: Jyväskylä
country: Finland
facility: StudyCor
city: Seinäjoki
country: Finland
facility: Seinäjoen keskussairaala
city: Le Coudray
country: France
facility: Les Hopitaux de Chartres-Hopital Louis Pasteur
city: Le Creusot
country: France
facility: Fondation Hôtel-Dieu
city: Le Creusot
country: France
facility: Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-2
city: Pessac
country: France
facility: Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2
city: Saint Herblain
country: France
facility: Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1
city: Venissieux
country: France
facility: Centre de Recherche Clinique Portes Du Sud
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Hamburg
country: Germany
facility: Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
city: Hohenmölsen
country: Germany
facility: Milek, Hohenmölsen
city: Oldenburg in Holstein
country: Germany
facility: RED-Institut für medizinische Forschung und Fortbildung GmbH
city: Rehlingen-Siersburg
country: Germany
facility: Praxis Dr. med. Wenzl-Bauer
city: Stuttgart
country: Germany
facility: Erlinger
city: Wangen
country: Germany
facility: Zentrum für klinische Studien Allgäu Oberschwaben
city: Chiba-shi, Chiba
country: Japan
facility: Chiba University Hospital_Diabetes, Metabolism and Endocrinology
city: Chiyoda-ku, Tokyo
country: Japan
facility: Suidoubashi Medical Clinic
city: Tokyo
country: Japan
facility: Higashi-shinjuku clinic
city: Lublin
country: Poland
facility: NZOZ Przychodnia Specjalistyczna Medica
state: Lubelski
city: Bialystok
country: Poland
facility: Gabinet Leczenia Otylosci i Chorob Dietozaleznych
state: Podlaskie Voivodeship
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
state: Pomorskie
city: Poznan
country: Poland
facility: Centrum Zdrowia Metabolicznego
state: Wielkopolskie Voivodeship
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej
city: Tumen
country: Russian Federation
facility: Tumen State Medical University
state: Russia
city: Dzerzhinskiy
country: Russian Federation
facility: LLC "Clinic of new technologies in Medicine"
city: Ekaterinburg
country: Russian Federation
facility: Joint Stock Company "Medical technologies"
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Endocrinology
city: Moscow
country: Russian Federation
facility: Endocrinological Dispensary of Department of healthcare ser.
city: Moscow
country: Russian Federation
facility: Federal Bureau for Medical and Social Expertise
city: Saint Petersburg
country: Russian Federation
facility: Joint Stock Company "Polyclinic Complex"
city: Saint Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References:
citation: 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.