Clinical trial NCT05564117: Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range
Official title: Efficacy and Safety of Oral Semaglutide 25 mg Once Daily in Adults With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-10-03
Enrollment: 307
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Number of participants who achieve body weight loss equal to or above 5 percent (yes/no)
timeFrame: At end of treatment (week 64)
Secondary outcomes:
measure: Number of participants who achieve body weight loss equal to or above 10 percent (yes/no)
timeFrame: At end of treatment (week 64)
measure: Number of participants who achieve body weight loss equal to or above 15 percent (yes/no)
timeFrame: At end of treatment (week 64)
measure: Number of participants who achieve body weight loss equal to or above 20 percent (yes/no)
timeFrame: At end of treatment (week 64)
measure: Change in Impact of Weight on Quality of Life-Lite-Clinical Trials version (IWQOL-Lite-CT) (Physical Function Domain [5-items] Score)
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Change in body mass index (BMI)
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Change in systolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Change in diastolic blood pressure
timeFrame: From randomisation (week 0) to end of treatment (week 64)
measure: Change in glycated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Change in lipid: Total cholesterol (ratio to baseline)
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Change in lipid: High-density lipoprotein (HDL) cholesterol (ratio to baseline)
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Change in lipid: Low-density lipoprotein (LDL) cholesterol (ratio to baseline)
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Change in lipid: Very-low-density lipoprotein (VLDL) cholesterol (ratio to baseline)
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Change in lipid: Triglycerides (ratio to baseline)
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Change in lipid: Free fatty acids (ratio to baseline)
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Change in high sensitivity C Reactive Protein
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Change in fasting plasma glucose (FPG)
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Change in fasting serum insulin
timeFrame: From baseline (week 0) to end of treatment (week 64)
measure: Number of treatment emergent adverse events
timeFrame: From baseline (week 0) to end of study (week 71)
measure: Number of treatment emergent serious adverse events
timeFrame: From baseline (week 0) to end of study (week 71)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univsty Of AL At Birmingham
state: Alabama
city: Costa Mesa
country: United States
facility: FDRC
state: California
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Dallas
country: United States
facility: UT Southwestern Med Cntr
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: Moncton
country: Canada
facility: G.A. Research Associates Ltd.
state: New Brunswick
city: Hamilton
country: Canada
facility: Wharton Med Clin Trials
state: Ontario
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Lingen
country: Germany
facility: Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
city: Münster
country: Germany
facility: MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
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: Villingen-Schwenningen
country: Germany
facility: Jacob, Villingen-Schwenningen
city: Wangen
country: Germany
facility: Zentrum für klinische Studien Allgäu Oberschwaben
city: Legnica
country: Poland
facility: Beata Mikłaszewicz&Dariusz Dąbrowski "CARDIAMED" s.j.
state: Dolnoslaskie
city: Lublin
country: Poland
facility: ETG Lublin
state: Lubelskie
city: Siedlce
country: Poland
facility: ETG Siedlce
state: Masovian
city: Warsaw
country: Poland
facility: ETG Warszawa
state: Masovian
city: Bialystok
country: Poland
facility: Gabinet Leczenia Otylosci i Chorob Dietozaleznych
state: Podlaskie Voivodeship
city: Poznan
country: Poland
facility: Centrum Zdrowia Metabolicznego
state: Wielkopolskie Voivodeship
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: