Semaglutide Use in Elderly Obese Patients

NCT05302596 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: STUDY00005760UL1TR001412
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, prospective, controlled, randomized and open label study to investigate the effect of the semaglutide addition to standard of care weight loss intervention (personalized lifestyle and exercise) in elderly obese subjects on body weight and body composition as assessed by DEXA.

Conditions

Obesity; Aging

Keywords

Body composition; Adipose tissue; semaglutide

Outcome Measures

Primary Outcomes (2)

• Body Composition as Total Fat Mass/ Total Fat-free Mass Ratio

  total fat mass/total fat-free mass ratio reported as arbitrary units (ratio), calculated by dividing total fat mass by total fat-free mass (lean mass) at baseline and at 16 weeks in both groups. Primary measurements of fat and fat-free mass is done using DEXA

  16 weeks

• Body Weight

  body weight reported in Kg at at baseline and at 16 weeks in both groups

  16 weeks

Secondary Outcomes (2)

• Total Fat Mass

  16 weeks

• Total Fat-free Mass (Lean Mass)

  16 weeks

Study Arms (2)

Semaglutide

EXPERIMENTAL

Semaglutide, added to standard of care, starting dose of 0.25mg titrated up to 1mg dose. for a total of 16 weeks.

Drug: Semaglutide Pen Injector

standard of care only

NO INTERVENTION

Standard of Care (SOC) weight loss intervention alone (personalized lifestyle and exercise)

Interventions

Semaglutide Pen Injector DRUG

semaglutide (up to 1mg) once weekly injection added to the standard of care weight loss program. Semaglutide dose will be started at 0.25 mg dose during the baseline visit and doubled every 2 weeks up to 1mg dose or up to maximum tolerable dose for total of 16 weeks of intervention

Also known as: Ozempic

Semaglutide

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Males and females age: ≥65 years
• BMI ≥30 Kg/m2 AND waist circumference for women: \> 80 cm and for men: \> 90 cm
• Stable body weight (no more than ±3 kg change during the 3 months prior to screening)
• Able to participate in personalized physical activities and dietary instructions.
• Participant must be able to read, write, and understand the English language and be able to provide written consent.

You may not qualify if:

• Current diagnosis of weight changing condition including cancer, gastrointestinal conditions or eating disorders
• GLP-1R agonists use within last 6 months
• Diagnosis of type 1 or 2 diabetes
• Impaired cognitive function (VA-St. Louis University Mental Survey (VA-SLUMS) score ≤ 19)
• History of chronic/idiopathic acute pancreatitis
• Personal/family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
• Previous surgical treatment for obesity
• Smoking or use of any nicotine products
• Use of any medication that could interfere with trial results especially weight management drugs
• Anticipated change in lifestyle (e.g., dietary, exercise or sleeping pattern) other than provided by the study.
• Hepatic disease or cirrhosis
• Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN) and/or Alanine aminotransferase (ALT) \> 3X ULN
• Inability to give informed consent
• History of gastroparesis
• History of serious hypersensitivity reaction to these agents

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Diabetes and Endocrinology Research Center

Buffalo, New York, 14221, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Husam Ghanim
• Organization: State University of NY at Buffalo

ghanim@buffalo.edu

7168818924

Study Officials

• Husam A Ghanim, PhD

  State University of NY at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Model Details: Single-center, prospective, controlled, randomized and open label study

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: September 1, 2022
• Primary Completion: October 23, 2023
• Study Completion: October 30, 2024
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)