Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range

Obesity Clinical Trial

— OASIS 4  

Official title:

Efficacy and Safety of Oral Semaglutide 25 mg Once Daily in Adults With Overweight or Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05564117
• Other study ID #: NN9932-4954
• Secondary ID: U1111-1271-90562
• Status: Completed
• Phase: Phase 3
• Start date: October 11, 2022
• Est. completion date: May 7, 2024

Study information

• Verified date: May 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. Participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: May 7, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study

• Male or female, age greater than or equal to 18 years at the time of signing informed consent

• Body mass index (BMI) of

• 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 (CV) 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:

• A self-reported change in body weight greater than 5 kg (11 pound [lbs]) within 90 days before screening irrespective of medical records

• HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Semaglutide
Semaglutide tablets orally once daily for 64 weeks.
• Placebo semaglutide
Semaglutide placebo-matching tablets orally once daily for 64 weeks.

Locations

Country	Name	City	State
Canada	Wharton Med Clin Trials	Hamilton	Ontario
Canada	G.A. Research Associates Ltd.	Moncton	New Brunswick
Germany	InnoDiab Forschung GmbH	Essen
Germany	Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz	Lingen
Germany	MedicalCenter am Clemenshospital	Münster
Germany	RED-Institut für medizinische Forschung und Fortbildung GmbH	Oldenburg in Holstein
Germany	Praxis Dr. med. Wenzl-Bauer	Rehlingen-Siersburg
Germany	Erlinger	Stuttgart
Germany	Jacob, Villingen-Schwenningen	Villingen-Schwenningen
Germany	Zentrum für klinische Studien Allgäu Oberschwaben	Wangen
Poland	Gabinet Leczenia Otylosci i Chorob Dietozaleznych	Bialystok	Podlaskie Voivodeship
Poland	Beata Miklaszewicz&Dariusz Dabrowski "CARDIAMED" s.j.	Legnica	Dolnoslaskie
Poland	ETG Lublin	Lublin	Lubelskie
Poland	Centrum Zdrowia Metabolicznego	Poznan	Wielkopolskie Voivodeship
Poland	ETG Siedlce	Siedlce	Masovian
Poland	ETG Warszawa	Warsaw	Masovian
United States	Washington Cntr Weight Mgmt	Arlington	Virginia
United States	Univsty Of AL At Birmingham	Birmingham	Alabama
United States	FDRC	Costa Mesa	California
United States	UT Southwestern Med Cntr	Dallas	Texas
United States	Accellacare	Wilmington	North Carolina
United States	Selma Medical Associates	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 64)
Primary	Number of participants who achieve body weight loss equal to or above 5 percent (yes/no)	Measured as count of participants.	At end of treatment (week 64)
Secondary	Number of participants who achieve body weight loss equal to or above 10 percent (yes/no)	Measured as count of participants.	At end of treatment (week 64)
Secondary	Number of participants who achieve body weight loss equal to or above 15 percent (yes/no)	Measured as count of participants.	At end of treatment (week 64)
Secondary	Number of participants who achieve body weight loss equal to or above 20 percent (yes/no)	Measured as count of participants.	At end of treatment (week 64)
Secondary	Change in Impact of Weight on Quality of Life-Lite-Clinical Trials version (IWQOL-Lite-CT) (Physical Function Domain [5-items] Score)	The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on participant's quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning.	From baseline (week 0) to end of treatment (week 64)
Secondary	Change in body mass index (BMI)	Measured in kilogram per square meter (kg/m^2).	From baseline (week 0) to end of treatment (week 64)
Secondary	Change in waist circumference	Measured in centimeter (cm).	From baseline (week 0) to end of treatment (week 64)
Secondary	Change in systolic blood pressure	Measured in millimeter of mercury (mmHg).	From baseline (week 0) to end of treatment (week 64)
Secondary	Change in diastolic blood pressure	Measured in mmHg.	From randomisation (week 0) to end of treatment (week 64)
Secondary	Change in glycated haemoglobin (HbA1c)	Measured in percentage point (%-point).	From baseline (week 0) to end of treatment (week 64)
Secondary	Change in lipid: Total cholesterol (ratio to baseline)	Change from baseline in total cholesterol at week 64 will be presented as ratio to baseline.	From baseline (week 0) to end of treatment (week 64)
Secondary	Change in lipid: High-density lipoprotein (HDL) cholesterol (ratio to baseline)	Change from baseline in HDL cholesterol at week 64 will be presented as ratio to baseline.	From baseline (week 0) to end of treatment (week 64)
Secondary	Change in lipid: Low-density lipoprotein (LDL) cholesterol (ratio to baseline)	Change from baseline in LDL cholesterol at week 64 will be presented as ratio to baseline.	From baseline (week 0) to end of treatment (week 64)
Secondary	Change in lipid: Very-low-density lipoprotein (VLDL) cholesterol (ratio to baseline)	Change from baseline in VLDL cholesterol at week 64 will be presented as ratio to baseline.	From baseline (week 0) to end of treatment (week 64)
Secondary	Change in lipid: Triglycerides (ratio to baseline)	Change from baseline in triglycerides at week 64 will be presented as ratio to baseline.	From baseline (week 0) to end of treatment (week 64)
Secondary	Change in lipid: Free fatty acids (ratio to baseline)	Change from baseline in free fatty acids at week 64 will be presented as ratio to baseline.	From baseline (week 0) to end of treatment (week 64)
Secondary	Change in high sensitivity C Reactive Protein	Change from baseline in high sensitivity C Reactive Protein at week 64 will be presented as ratio to baseline.	From baseline (week 0) to end of treatment (week 64)
Secondary	Change in fasting plasma glucose (FPG)	Change from baseline in FPG at week 64 will be presented as ratio to baseline.	From baseline (week 0) to end of treatment (week 64)
Secondary	Change in fasting serum insulin	Change from baseline in fasting serum insulin at week 64 will be presented as ratio to baseline.	From baseline (week 0) to end of treatment (week 64)
Secondary	Number of treatment emergent adverse events	Measured as count of events.	From baseline (week 0) to end of study (week 71)
Secondary	Number of treatment emergent serious adverse events	Measured as count of events.	From baseline (week 0) to end of study (week 71)