GLP-1s to Enhance Lasting Optimal Weight

NCT06861439 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB00127025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to examine how tirzepatide affects body composition, bone health, and physical performance in older adults over a nine-month period. Participants will take tirzepatide weekly, have clinic visits every 4 weeks, meet study doctor and registered dietitian every 4 weeks in person or video conference, attend group intervention sessions twice a month via video conference, weigh daily with a study-provided smart scale, keep a record of all foods and beverages consumed, and use a study-provided activity tracker to keep track of daily step counts.

Conditions

Obesity

Keywords

Weight Loss; Muscle Loss; Physical Disability; Bone Density; Older Adults

Outcome Measures

Primary Outcomes (8)

• Change in total body lean mass

  Change in total body lean mass will be measured by DXA scan

  Baseline to Month 9

• Change in appendicular lean mass

  Change in appendicular lean mass will be measured by DXA scan

  Baseline to Month 9

• Change in total body fat mass

  Change in total body fat mass will be measured by DXA scan

  Baseline to Month 9

• Change in total hip bone mineral density

  Change in total hip bone mineral density will be measured by DXA scan

  Baseline to Month 9

• Change in lumbar spine bone mineral density

  Change in lumbar spine bone mineral density will be measured by DXA scan

  Baseline to Month 9

• Change in 400 meter walk time

  Change in the time it takes to walk 400 meters (10 laps on an indoor, 20-meter course). The 400 meter walk is a test of exercise tolerance and aerobic fitness.

  Baseline to Month 9

• Change in lower extremity physical performance score

  Change in lower extremity physical performance will be assessed by the expanded Short Physical Performance Battery. Activities include side-by-side, semi-tandem, tandem and one leg stand balance tests; 4 meter walk; 4 meter narrow walk; and time to rise from a chair five times. Total score ranges from 0-4 with higher scores indicating better lower extremity physical performance.

  Baseline to Month 9

• Change in leg strength

  Change in leg extensor strength will be assessed using the Keiser AIR300 Leg Press System.

  Baseline to Month 9

Secondary Outcomes (11)

• Change in thigh intramuscular fat tissue

  Baseline to Month 9

• Change in thigh muscle volume

  Baseline to Month 9

• Change in total skeletal muscle mass

  Baseline to Month 9

• Change in total volumetric bone mineral density of the hip

  Baseline to Month 9

• Change in hip bone strength

  Baseline to Month 9

Study Arms (1)

Tirzepatide

EXPERIMENTAL

Tirzepatide injection once weekly for 9 months

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

Tirzepatide will be initiated at a dose of 2.5 mg weekly and increased as tolerated to 5 mg weekly at four weeks for the remainder of the 9-month intervention period. Participants who are unable to tolerate the 5 mg dose will be decreased to the 2.5 mg dose.

Also known as: Zepbound

Tirzepatide

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• BMI 30-37 kg/m2 or BMI 27-\<30 kg/m2 with at least 1 weight-related comorbidity
• community dwelling
• able to provide own transportation to study visits
• willing to provide informed consent
• willing to take terzepatide for 9 months
• agree to all study procedures/assessments
• approved for participation by the study physician

You may not qualify if:

• dependent on a cane or walker or needing assistance with any activity of daily living
• history of mild cognitive impairment or dementia or cognitive impairment on Montreal Cognitive Assessment (MoCA score \<22)
• evidence of depressive symptoms (Center for Epidemiologic Studies Depression scale score =\>16
• use of \>1 tobacco product/day or 4/week or vaped \>1/week in past year
• excessive alcohol use in past month (\>7 drinks/week for women; \>14 drinks/week for men)
• weight loss or gain \>5% in past 3 months
• vegan or other severe dietary restriction
• history of binge eating disorder
• regular participation in high intensity aerobic or resistance exercise training \>150 mins/week
• severe arthritis, fracture, chronic injury, or other musculoskeletal disorder that prevents walking independently
• joint replacement or other orthopedic surgery in past 6 months or planned in next 12 months
• osteoporosis (self report or DXA t-score \<= -2.5 on total hip and/or femoral neck)
• uncontrolled hypertension (systolic \>160 OR diastolic \>100 mmHg) upon repeated assessments
• type 1 diabetes
• uncontrolled type 2 diabetes (HbA1c \>7.5%), type 2 diabetes diagnosed within last year, or newly identified type 2 diabetes (HbA1c \>6.5%)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Muscular Atrophy

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Denise Houston, PhD

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 6, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)