Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range
- Registration Number
- NCT05564117
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 307
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral semaglutide 25 mg Semaglutide Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 64 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), and 25 mg (weeks 13 to 64). Oral semaglutide placebo Placebo semaglutide Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.
- Primary Outcome Measures
Name Time Method Relative change in body weight From baseline (week 0) to end of treatment (week 64) Measured in percentage (%).
Number of participants who achieve body weight loss equal to or above 5 percent (yes/no) At end of treatment (week 64) Measured as count of participants.
- Secondary Outcome Measures
Name Time Method Change in systolic blood pressure From baseline (week 0) to end of treatment (week 64) Measured in millimeter of mercury (mmHg).
Change in diastolic blood pressure From randomisation (week 0) to end of treatment (week 64) Measured in mmHg.
Change in lipid: Total cholesterol (ratio to baseline) From baseline (week 0) to end of treatment (week 64) Change from baseline in total cholesterol at week 64 will be presented as ratio to baseline.
Change in fasting plasma glucose (FPG) From baseline (week 0) to end of treatment (week 64) Change from baseline in FPG at week 64 will be presented as ratio to baseline.
Number of participants who achieve body weight loss equal to or above 10 percent (yes/no) At end of treatment (week 64) Measured as count of participants.
Number of participants who achieve body weight loss equal to or above 20 percent (yes/no) At end of treatment (week 64) Measured as count of participants.
Change in Impact of Weight on Quality of Life-Lite-Clinical Trials version (IWQOL-Lite-CT) (Physical Function Domain [5-items] Score) From baseline (week 0) to end of treatment (week 64) 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.
Change in waist circumference From baseline (week 0) to end of treatment (week 64) Measured in centimeter (cm).
Change in lipid: Low-density lipoprotein (LDL) cholesterol (ratio to baseline) From baseline (week 0) to end of treatment (week 64) Change from baseline in LDL cholesterol at week 64 will be presented as ratio to baseline.
Change in lipid: Very-low-density lipoprotein (VLDL) cholesterol (ratio to baseline) From baseline (week 0) to end of treatment (week 64) Change from baseline in VLDL cholesterol at week 64 will be presented as ratio to baseline.
Change in lipid: Triglycerides (ratio to baseline) From baseline (week 0) to end of treatment (week 64) Change from baseline in triglycerides at week 64 will be presented as ratio to baseline.
Change in high sensitivity C Reactive Protein From baseline (week 0) to end of treatment (week 64) Change from baseline in high sensitivity C Reactive Protein at week 64 will be presented as ratio to baseline.
Change in fasting serum insulin From baseline (week 0) to end of treatment (week 64) Change from baseline in fasting serum insulin at week 64 will be presented as ratio to baseline.
Number of treatment emergent adverse events From baseline (week 0) to end of study (week 71) Measured as count of events.
Change in glycated haemoglobin (HbA1c) From baseline (week 0) to end of treatment (week 64) Measured in percentage point (%-point).
Change in lipid: High-density lipoprotein (HDL) cholesterol (ratio to baseline) From baseline (week 0) to end of treatment (week 64) Change from baseline in HDL cholesterol at week 64 will be presented as ratio to baseline.
Number of participants who achieve body weight loss equal to or above 15 percent (yes/no) At end of treatment (week 64) Measured as count of participants.
Change in lipid: Free fatty acids (ratio to baseline) From baseline (week 0) to end of treatment (week 64) Change from baseline in free fatty acids at week 64 will be presented as ratio to baseline.
Number of treatment emergent serious adverse events From baseline (week 0) to end of study (week 71) Measured as count of events.
Change in body mass index (BMI) From baseline (week 0) to end of treatment (week 64) Measured in kilogram per square meter (kg/m\^2).
Trial Locations
- Locations (22)
ETG Siedlce
🇵🇱Siedlce, Masovian, Poland
ETG Warszawa
🇵🇱Warsaw, Masovian, Poland
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
🇩🇪Münster, Germany
Univsty Of AL At Birmingham
🇺🇸Birmingham, Alabama, United States
FDRC
🇺🇸Costa Mesa, California, United States
Accellacare
🇺🇸Wilmington, North Carolina, United States
UT Southwestern Med Cntr
🇺🇸Dallas, Texas, United States
Washington Cntr Weight Mgmt
🇺🇸Arlington, Virginia, United States
Selma Medical Associates
🇺🇸Winchester, Virginia, United States
G.A. Research Associates Ltd.
🇨🇦Moncton, New Brunswick, Canada
Wharton Med Clin Trials
🇨🇦Hamilton, Ontario, Canada
InnoDiab Forschung GmbH
🇩🇪Essen, Germany
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
🇩🇪Lingen, 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, Germany
Beata Mikłaszewicz&Dariusz Dąbrowski "CARDIAMED" s.j.
🇵🇱Legnica, Dolnoslaskie, Poland
ETG Lublin
🇵🇱Lublin, Lubelskie, Poland
Gabinet Leczenia Otylosci i Chorob Dietozaleznych
🇵🇱Bialystok, Podlaskie Voivodeship, Poland
Centrum Zdrowia Metabolicznego
🇵🇱Poznan, Wielkopolskie Voivodeship, Poland