Research Study on How Well Oral Semaglutide Works for Weight Loss in Adults With Excess Body Weight

Phase 3RecruitingNCT07770841

Novo Nordisk A/S450 enrolled

Overview

The purpose of this study is to see how oral semaglutide, when taken in lower doses help lowering of body weight in participants with excess body weight when compared to 'dummy' tablets (placebo). Results from this study will help select the most optimal lower dose of oral semaglutide that can be used for treating participants living with overweight or obesity.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

450

Conditions

Overweight Obesity

Interventions

SemaglutideDRUG

Participants will receive semaglutide orally.

PlaceboDRUG

Participants will receive placebo orally.

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. * Female or male (sex at birth). * Age 18 years or above at the time of signing the informed consent. * Body mass index (BMI) of 1. ≥ 27.0 kilogram per square meter (kg/m\^2) with the presence of at least one weight-related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or CV disease. OR 2. ≥ 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% within 90 days before screening irrespective of medical records. * HbA1c ≥ 6.5% (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening. * Consistent use of glucagon like peptide-1 (GLP-1) receptor agonists, including medication with glucagon like peptide-1 receptor agonist (GLP-1 RA) activity like dual GLP-1/gastric inhibitory peptide RAs, or amylin analogues before screening. Consistent use is defined as treatment.

Locations (62)

Outcomes

Primary Outcomes

Relative change in body weight

Measured as percentage change in body weight.

Time frame: From baseline (week 0) to week 60

Secondary Outcomes

Achievement of body weight reduction greater than or equal to (≥) 5 percentage (%) (Yes/No)

Measured as count of participant.

Time frame: At week 60

Achievement of body weight reduction ≥ 10% (Yes/No)

Measured as count of participant.

Time frame: At week 60

Achievement of body weight reduction ≥ 15% (Yes/No)

Measured as count of participant.

Time frame: At week 60

Change in waist circumference

Measured as centimeter (cm).

Time frame: From baseline (week 0) to week 60

Change in body weight

Measured as kilogram (kg).

Time frame: From baseline (week 0) to week 60

Change in high sensitivity C-Reactive Protein (hsCRP)

Measured as milligrams per deciliter (mg/dL).

Time frame: From baseline (week 0) to week 60

Change in systolic blood pressure

Measured as millimetres of mercury (mmHg).

Time frame: From baseline (week 0) to week 60

Change in diastolic blood pressure

Central Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178 clinicaltrials@novonordisk.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Uni of Alabama at Birmingham

Birmingham, Alabama, United States

RECRUITING

Headlands Research California, LLC

Escondido, California, United States

RECRUITING

National Research Institute - Huntington Park

Huntington Park, California, United States

RECRUITING

Los Angeles Institute for Metabolic Research

Los Angeles, California, United States

RECRUITING

ERG Holding Company, LLC / Evolution Research Group, LLC

Delray Beach, Florida, United States

RECRUITING

ERG Holding Company, LLC / Evolution Research Group, LLC

Fort Myers, Florida, United States

RECRUITING

Jedidiah Clinical Research

Tampa, Florida, United States

RECRUITING

East West Med Res Inst

Honolulu, Hawaii, United States

RECRUITING

L-MARC Research Center

Louisville, Kentucky, United States

RECRUITING

StudyMetrix Research LLC

City of Saint Peters, Missouri, United States

RECRUITING

...and 52 more locations

Time frame: From baseline (week 0) to week 60

Change in fasting plasma glucose (FPG)

Measured as ratio to baseline.

Time frame: From baseline (week 0) to week 60

Change in glycated haemoglobin (HbA1c)

Measured as %-point.

Time frame: From baseline (week 0) to week 60

Change in glycaemic status

Measured as count of participants.

Time frame: From baseline (week 0) to week 60

Change in lipids: Total cholesterol

Measured as ratio to baseline.

Time frame: From baseline (week 0) to week 60

Change in lipids: High density lipoprotein (HDL) cholesterol

Measured as ratio to baseline.

Time frame: From baseline (week 0) to week 60

Change in lipids: Non-HDL cholesterol

Measured as ratio to baseline.

Time frame: From baseline (week 0) to week 60

Change in lipids: Low density lipoprotein (LDL) cholesterol

Measured as ratio to baseline.

Time frame: From baseline (week 0) to week 60

Change in lipids: Very low density lipoprotein (VLDL) cholesterol

Measured as ratio to baseline.

Time frame: From baseline (week 0) to week 60

Change in lipids: Triglycerides

Measured as ratio to baseline.

Time frame: From baseline (week 0) to week 60

Change in lipids: Free fatty acids

Measured as ratio to baseline.

Time frame: From baseline (week 0) to week 60

Change in waist-height ratio (WtHR)

Measured as change in waist-height ratio.

Time frame: From baseline (week 0) to week 60

Number of treatment emergent adverse events

Measured as count of events.

Time frame: From baseline (week 0) to week 67

Number of treatment emergent serious adverse events

Measured as count of events.

Time frame: From baseline (week 0) to week 67

Number of treatment emergent adverse events leading to permanent treatment discontinuation

Measured as count of events.

Time frame: From baseline (week 0) to week 67