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

Novo Nordisk A/S307 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

307

Conditions

Overweight Obesity

Interventions

SemaglutideDRUG

Semaglutide tablets orally once daily for 64 weeks.

Placebo semaglutideDRUG

Semaglutide placebo-matching tablets orally once daily for 64 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (23)

Univsty Of AL At Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Percentage Change in Body Weight

Percentage change in body weight from baseline (week 0) to end of treatment (week 64) is presented.

Time frame: Baseline (week 0), end of treatment (week 64)

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

Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.

Time frame: At end of treatment (week 64)

Secondary Outcomes

Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)

Number of participants who achieved ≥ 10% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction.

Time frame: At end of treatment (week 64)

Number of Participants Who Achieved Body Weight Reduction ≥ 15% (Yes/No)

Number of participants who achieved ≥ 15% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 15% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 15% weight reduction.

Time frame: At end of treatment (week 64)

Number of Participants Who Achieved Body Weight Reduction ≥ 20% (Yes/No)

Number of participants who achieved ≥ 20% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 20% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 20% weight reduction.

Data from ClinicalTrials.gov

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FDRC

Costa Mesa, California, United States

East West Medical Research Institute_Honolulu

Honolulu, Hawaii, 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

...and 13 more locations

Time frame: At end of treatment (week 64)

Change in Physical Function Domain (5-items) Score Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT)

Change in physical function domain score IWQOL-Lite-CT from baseline (week 0) to the end of treatment (week 64) is presented. IWQOL-Lite-CT is a 20-item obesity-specific PRO measures used to assess the impact of body weight changes on patient's physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial functioning (13 items) in 3 composite scores (Physical Function, Physical and Psychosocial) and a Total score, all ranging from 0 to 100 with higher scores reflecting better levels of functioning. This outcome measure shows results for 'physical function domain'.

Time frame: Baseline (week 0), end of treatment (week 64)

Number of Participants Who Achieved ≥14.6 IWQOL-Lite-CT Physical Function Domain (PFD) Score (Yes/No)

Number of participants who achieved ≥14.6 in IWQOL-Lite-CT PFD score (Yes/No) from baseline to end of treatment (week 64) is presented. IWQOL-Lite-CT is a 20-item obesity-specific PRO measures used to assess the impact of body weight changes on patient's physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial functioning (13 items) in 3 composite scores (Physical Function, Physical and Psychosocial) and a Total score, all ranging from 0 to 100 with higher scores reflecting better levels of functioning.

Time frame: Baseline (week 0), end of treatment (week 64)

Change in Body Weight - Kilogram (kg)

Change in body weight from baseline (week 0) to end of treatment (week 64) is presented.

Time frame: Baseline (week 0), end of treatment (week 64)

Change in Body Mass Index (BMI)

Change in BMI from baseline (week 0) to end of treatment (week 64) is presented.

Time frame: Baseline (week 0), end of treatment (week 64)

Change in Waist Circumference

Change in waist circumference from baseline (week 0) to end of treatment (week 64) is presented.

Time frame: Baseline (week 0), end of treatment (week 64)

Change in Systolic Blood Pressure

Change in systolic blood pressure from baseline (week 0) to end of treatment (week 64) is presented.

Time frame: Baseline (week 0), end of treatment (week 64)

Change in Diastolic Blood Pressure

Change in diastolic blood pressure from randomisation (week 0) to end of treatment (week 64) is presented.

Time frame: Randomisation (week 0), end of treatment (week 64)

Change in Glycosylated Haemoglobin (HbA1c)

Change in HbA1c from baseline (week 0) to end of treatment (week 64) is presented.

Time frame: Baseline (week 0), end of treatment (week 64)

Change in Total Cholesterol - Ratio to Baseline

Change in total cholesterol (measured in millimoles per liter \[mmol/L\]) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

Time frame: Baseline (week 0), end of treatment (week 64)

Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline

Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

Time frame: Baseline (week 0), end of treatment (week 64)

Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline

Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

Time frame: Baseline (week 0), end of treatment (week 64)

Change in Very Low-Density Lipoproteins (VLDL) Cholesterol - Ratio to Baseline

Change in VLDL cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

Time frame: Baseline (week 0), end of treatment (week 64)

Change in Triglycerides - Ratio to Baseline

Change in triglycerides (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

Time frame: Baseline (week 0), end of treatment (week 64)

Change in Free Fatty Acids - Ratio to Baseline

Change in free fatty acids (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

Time frame: Baseline (week 0), end of treatment (week 64)

Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline

Change in high sensitivity C-Reactive Protein (hsCRP) (milligram per litre \[mg/L\]) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

Time frame: Baseline (week 0), end of treatment (week 64)

Change in Fasting Plasma Glucose (FPG)

Change in FPG measured in milligrams per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 64) is presented.

Time frame: Baseline (week 0), end of treatment (week 64)

Change in Fasting Serum Insulin - Ratio to Baseline

Change in fasting serum insulin measured in picomoles per liter (pmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

Time frame: Baseline (week 0), end of treatment (week 64)

Number of Participants With Body Mass Index (BMI) Less Than (<) 30 at Week 64 (Yes/no)

Number of participants with BMI \<30 at the end of treatment (week 64) from baseline (week 0) is presented. The outcome measure is applicable for participants with BMI ≥ 30 at baseline (week 0). In the reported data, 'Yes' infers the number of participants who have achieved BMI less than 30, whereas 'No' infers the number of participants who have not achieved BMI less than 30 at week 64.

Time frame: From baseline (week 0) to end of treatment (week 64)

Number of Participants With Change in Glycaemic Status

Number of participants with change in glycaemic status from baseline (week 0) to the end of treatment (week 64) is presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) \<5.7%; 2) Pre-diabetes: 5.7% \<= HbA1c \< 6.5% 3) Type 2 diabetes: HbA1c \>=6.5%.

Time frame: Baseline (week 0), end of treatment (week 64)

Number of Treatment Emergent Adverse Events (TEAEs)

Number of treatment emergent adverse events from baseline (week 0) to end of study (week 71) is presented. An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.

Time frame: From baseline (week 0) to end of study (week 71)

Number of Serious Treatment Emergent Adverse Events

Number of treatment emergent serious adverse events from baseline (week 0) to end of study (week 71) is presented. A serious adverse event (SAE) is any untoward medical occurrence that fulfils at least one of following criteria: results in death; is life-threatening; requires inpatient or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is congenital anomaly/birth defect; important medical event.

Time frame: From baseline (week 0) to end of study (week 71)

Change in Pulse

Change in pulse from baseline (week 0) to end of treatment (week 64) is presented.

Time frame: Baseline (week 0), end of treatment (week 64)