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Semaglutide for Obesity

Phase 4
Waitlist Available
Led By Husam A Ghanim, PhD
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females age: ≥65 years
BMI ≥30 Kg/m2 AND waist circumference for women: > 80 cm and for men: > 90 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This triallooks at how adding semaglutide to personalized lifestyle/exercise helps elderly obese people lose weight & improve body composition.

Who is the study for?
This trial is for men and women aged 65 or older who are obese, with a BMI of at least 30 and specific waist measurements. They must have had a stable body weight recently, be able to understand English and consent forms, and follow diet and exercise plans. People with diabetes, past obesity surgery, certain liver diseases, cognitive impairments, eye problems related to diabetes, or those using similar drugs can't join.Check my eligibility
What is being tested?
The study tests if adding Semaglutide (a drug delivered by pen injector) to standard weight loss care helps elderly obese patients lose more weight. It's compared with just the standard care alone. Participants will be randomly assigned to either receive Semaglutide or not in an open-label setting where both doctors and participants know which treatment is given.See study design
What are the potential side effects?
Semaglutide may cause digestive issues like nausea or diarrhea; it could also lead to low blood sugar levels especially if you're on other medications that affect blood sugar. There's a small risk of pancreatitis (inflammation of the pancreas), allergic reactions, changes in vision due to swelling in the back of the eye (macular edema), gallbladder problems like gallstones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 65 years old or older.
Select...
My BMI is 30 or higher and my waist size meets the criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in body composition
Change in body weight
Secondary outcome measures
Change in adipose tissue metabolism
change in adipose tissue energy expenditure

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220
29%
Nasopharyngitis
9%
Constipation
9%
Nausea
8%
Upper respiratory tract inflammation
6%
Back pain
6%
Diarrhoea
5%
Decreased appetite
3%
Influenza
3%
Diabetic retinopathy
2%
Atrioventricular block second degree
2%
Abdominal discomfort
2%
Vomiting
2%
Angina pectoris
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dulaglutide 0.75 mg
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg
Oral Semaglutide 14 mg

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SemaglutideExperimental Treatment1 Intervention
Semaglutide, added to standard of care, starting dose of 0.25mg titrated up to 1mg dose. for a total of 16 weeks.
Group II: standard of care onlyActive Control1 Intervention
Standard of Care (SOC) weight loss intervention alone (personalized lifestyle and exercise)

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
320 Previous Clinical Trials
401,714 Total Patients Enrolled
12 Trials studying Obesity
4,019 Patients Enrolled for Obesity
State University of New York at BuffaloLead Sponsor
246 Previous Clinical Trials
49,472 Total Patients Enrolled
18 Trials studying Obesity
9,931 Patients Enrolled for Obesity
Husam A Ghanim, PhDPrincipal InvestigatorState University of NY at Buffalo

Media Library

Semaglutide Clinical Trial Eligibility Overview. Trial Name: NCT05302596 — Phase 4
Obesity Research Study Groups: Semaglutide, standard of care only
Obesity Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT05302596 — Phase 4
Semaglutide 2023 Treatment Timeline for Medical Study. Trial Name: NCT05302596 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being accepted for the research project?

"Clinicaltrials.gov officially states that this medical trial is still looking to enroll patients. It was originally posted on September 1st 2022 and the details were recently updated on October 24th 2022."

Answered by AI

Are there any potential hazards associated with Semaglutide treatment?

"As this is a stage 4 trial, Semaglutide's safety was rated 3 due to its existing approval status."

Answered by AI

How many individuals are currently enrolled in this trial?

"Affirmative. According to the clinicaltrials.gov page, this clinical trial is currently seeking participants and was published on September 1st 2022 with its last update occurring on October 24th of that same year. The study requires 16 patients from a single site."

Answered by AI

Who else is applying?

What site did they apply to?
Diabetes and Endocrinology Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Semaglutide Use in Elderly Obese Patients
Husam A Ghanim 2022. "Semaglutide Use in Elderly Obese Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05302596.
~6 spots leftby Apr 2025
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