Obesity study: Semaglutide vs Therapy Cessation
Official title Glucagon-like Peptide 1 (GLP-1) Receptor Agonist Therapy and Exercise Training in People With Obesity
ClinicalTrials.gov ID: NCT07091500
What this study is testing
What is Semaglutide?
Semaglutide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how a year of GLP‑1 drug treatment, with or without an exercise program, affects muscle mass, strength, metabolism and brain signals, and what happens after the drug is stopped for another year.
- Who it's for
- Adults who are classified as having obesity.
- What's involved
- Participants will be randomly assigned to receive a GLP‑1 medication alone or the medication plus a supervised exercise program for one year. They will have regular clinic visits for medication checks, exercise sessions, and tests such as body‑composition scans, strength measurements, metabolic labs and brain imaging.
- Time commitment
- The trial lasts two years: one year of treatment with regular visits, followed by a one‑year follow‑up after stopping the medication.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 75
You may be able to join if
- i) obesity (Body Mass Index ≥ 30 kg/m2)
- ii) decreased physical function (Modified Physical Performance Test score 17 to 31)
- iii) approval of their primary physician to participate in this study.
You likely can't join if
- i) unstable weight (\>4% change during the last 2 months before entering the study)
- ii) ≥150 min per week of structured exercise (e.g., jogging, activities that cause heavy breathing and sweating)
- iii) diabetes
- iv) significant cardiopulmonary disease (heart failure, angina, uncontrolled hypertension, chronic obstructive pulmonary disease) or other organ...
- v) therapy with a GLP-1 or other weight loss medications
- vi) clinically significant gastric emptying abnormality or chronically take drugs that directly affect gastrointestinal motility
See the full eligibility criteria
- i) obesity (Body Mass Index ≥ 30 kg/m2)
- ii) decreased physical function (Modified Physical Performance Test score 17 to 31)
- iii) approval of their primary physician to participate in this study.
- i) unstable weight (\>4% change during the last 2 months before entering the study)
- ii) ≥150 min per week of structured exercise (e.g., jogging, activities that cause heavy breathing and sweating)
- iii) diabetes
- iv) significant cardiopulmonary disease (heart failure, angina, uncontrolled hypertension, chronic obstructive pulmonary disease) or other organ dysfunction (e.g., renal insufficiency [eGFR \<30 mL/min/1.73 m2])
- v) therapy with a GLP-1 or other weight loss medications
- vi) clinically significant gastric emptying abnormality or chronically take drugs that directly affect gastrointestinal motility
- vii) history of chronic or acute pancreatitis
- viii) thyroid-stimulating hormone (TSH) \>1.5X the upper limit of normal (patients receiving treatment for hypothyroidism may be included provided their thyroid hormone replacement dose has been stable for at least 3...
- ix) history of significantly active or unstable Major Depressive Disorder or other severe psychiatric disorder (e.g.
- x) acute or chronic hepatitis, or other liver disease other than Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD)
- xi) family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- xii) history of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer)...
- xiii) tobacco use, excessive alcohol intake (≥3 drinks/day for men and ≥2 drinks/day for women) or active substance abuse with illegal drugs by self-report, or regular marijuana use within 3 months of enrollment and...
- xiv) Use of medications that are known to affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued for this study
- xv) have had bariatric surgery or plan to have endoscopic or bariatric surgery therapy for obesity
- xvi) anemia (Hgb \<10 g/dL)
- xvii) Conditions that render subject unable to complete all testing procedures (e.g., severe ambulatory impairments, limb amputations, or metal implants that interfere with imaging procedures; coagulation disorders)
- xii) history of seizure disorder
- xix) Female who is pregnant, breast-feeding or intends to become pregnant
- xx) allergy or hypersensitivity to GLP-1 RA medications
- xxi) unable to grant voluntary informed consent
- xxii) unable or unwilling to follow the study protocol or who, for any reason, the research team considers the participant is not an appropriate candidate for the study
The study team makes the final eligibility decision.
Where it is enrolling
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at St Louis, Missouri, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.