STEP 1Weight Loss Evaluation with Semaglutide in Overweight or Obese Individuals
This study aims to evaluate the effectiveness of Semaglutide in helping overweight or obese individuals lose weight, by measuring the change in body weight percentage and the number of participants who achieve a weight loss of 5% or more over a period of 68 weeks.
Semaglutide
+ Placebo (semaglutide)
Body Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Treatment Study
Summary
Study start date: June 4, 2018
Actual date on which the first participant was enrolled.This study focuses on individuals who are overweight or obese. The main goal is to evaluate the effectiveness and safety of a new medicine called Semaglutide 2.4 mg, taken once a week. The study aims to measure changes in body weight from the start to the end of the study, comparing the weight loss of participants taking Semaglutide with those taking a 'dummy' medicine. Participants will also receive guidance on healthy food choices, physical activity, and weight loss strategies. The study is important as it could potentially provide a new treatment option for individuals struggling with weight management. During the study, participants will be randomly assigned to receive either Semaglutide or the 'dummy' medicine. The medicine will be injected once a week using a thin needle in the stomach, thigh, or upper arm. The main phase of the study lasts about 1.5 years, involving 15 clinic visits and 10 phone calls with the study doctor. In some countries, approximately 300 participants will continue to an extension phase for about 2.5 years, attending an additional 5 follow-up visits. The study will measure the percentage of body weight change and the number of participants who achieve a weight loss of 5% or more. These measurements will be taken from the start of the study to week 68, covering both the period when participants are on treatment and the 2 weeks following the last treatment.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1961 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Main phase: * Male or female, age greater than or equal to 18 years at the time of signing informed consent * Body mass index (BMI) greater than or equal to 30.0 kg/sqm or greater than or equal to 27.0 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease * History of at least one self-reported unsuccessful dietary effort to lose body weight Extension phase: * Informed consent for the extension phase obtained before any trial related activities for the extension phase * On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo Exclusion Criteria: Main phase: * Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening * A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records Extension phase: * Female who is pregnant or intends to become pregnant during the extension phase * Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's compliance with the extension of the trial
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 128 locations
Novo Nordisk Investigational Site
Crystal River, United StatesOpen Novo Nordisk Investigational Site in Google MapsNovo Nordisk Investigational Site
Jacksonville, United StatesNovo Nordisk Investigational Site
Jacksonville, United StatesNovo Nordisk Investigational Site
Ocala, United States