GLP-1s to Enhance Lasting Optimal Weight (GLOW)

October 27, 2025 updated by: Wake Forest University Health Sciences

Effects of Tirzepatide on Fat-Free Mass, Bone and Physical Function in Older Adults - a Pilot Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will enroll 40 older adults with obesity (or overweight with a weight-related comorbidity) in a 9-month pilot to examine the effects of tirzepatide on body composition, bone health, and physical performance. All participants will receive tirzepatide, 5 mg per week and counseling sessions (group and individual) on diet quality and physical activity as well as behavioral strategies to facilitate dietary and physical activity changes. Participants will be expected to weigh themselves daily on a smart scale, record their food and beverage consumption, and keep track of daily step counts over the 9-month intervention period. Body composition, bone health, and physical performance will be measured at baseline prior to intervention and approximately nine months later. This data will be used to examine the effects of tirzepatide on total and appendicular lean and total fat mass measured by DXA; hip and spine bone mineral density measured by DXA; and leg strength and physical performance (expanded Short Physical Performance Battery, 400-m walk).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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%)
  • dialysis or abnormal kidney function (eGFR <30 ml/min/1.73m2)
  • liver disease or abnormal liver function (ALT levels 2 times above normal limit)
  • severe anemia (Hb <11 g/dL)
  • potassium or sodium above or below normal limits
  • uncontrolled thyroid disease (hypo/hyper) or requiring recent (past 3 months) adjustments in thyroid hormone supplementation or TSH <0.45 or >4.5 mU/L
  • stroke, heart attack, heart failure hospitalization, or revascularization procedure within the past year; New York heart failure Class >2; COPD requiring oxygen use; uncontrolled angina; PAD diagnosis within the last year; progressive neurologic disease (e.g., Parkinson's, ALS, MS); other diseases suggesting a life-expectancy <3 years
  • personal or family history of medullary thyroid carcinoma, history of multiple endocrine neoplasia syndrome type 2, or any other cancer (except non-melanoma skin cancers) requiring treatment in past year
  • history of gastroparesis or pancreatitis
  • cholelithiasis, severe irritable bowel syndrome or Crohn's disease
  • history of stomach or small intestinal surgery (except appendectomy but including surgery for weight loss)
  • recent (within 4 weeks) acute respiratory illness including influenza, COVID-19
  • overnight hospitalization within the past 6 months
  • regular use of growth hormones, medications prescribed for weight management, prescription osteoporosis medications, certain prescription medications for diabetes including insulin, sulfonylurea, meglitinides, GLP-1 agonists, SGLT2 inhibitors
  • use of oral steroids for >1 month within the last 3 months
  • current participation in another intervention research study
  • planned out of town trips greater than 3 weeks in the next year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tirzepatide
Tirzepatide injection once weekly for 9 months
Drug: Tirzepatide
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.
Other Names:
  • Zepbound

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in total body lean mass
Time Frame: Baseline to Month 9
Change in total body lean mass will be measured by DXA scan
Baseline to Month 9
Change in appendicular lean mass
Time Frame: Baseline to Month 9
Change in appendicular lean mass will be measured by DXA scan
Baseline to Month 9
Change in total body fat mass
Time Frame: Baseline to Month 9
Change in total body fat mass will be measured by DXA scan
Baseline to Month 9
Change in total hip bone mineral density
Time Frame: Baseline to Month 9
Change in total hip bone mineral density will be measured by DXA scan
Baseline to Month 9
Change in lumbar spine bone mineral density
Time Frame: Baseline to Month 9
Change in lumbar spine bone mineral density will be measured by DXA scan
Baseline to Month 9
Change in 400 meter walk time
Time Frame: Baseline to Month 9
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
Time Frame: Baseline to Month 9
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
Time Frame: Baseline to Month 9
Change in leg extensor strength will be assessed using the Keiser AIR300 Leg Press System.
Baseline to Month 9

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in thigh intramuscular fat tissue
Time Frame: Baseline to Month 9
Change in thigh intramuscular fat tissue will be measured by CT scan
Baseline to Month 9
Change in thigh muscle volume
Time Frame: Baseline to Month 9
Change in thigh muscle volume will be measured by CT scan
Baseline to Month 9
Change in total skeletal muscle mass
Time Frame: Baseline to Month 9
Change in total skeletal muscle mass will be assessed by D3 creatine
Baseline to Month 9
Change in total volumetric bone mineral density of the hip
Time Frame: Baseline to Month 9
Change in total volumetric bone mineral density of the hip will be measured by CT scan
Baseline to Month 9
Change in hip bone strength
Time Frame: Baseline to Month 9
Change in hip bone strength will be measured by CT scan
Baseline to Month 9
Change in total volumetric bone mineral density of the radius
Time Frame: Baseline to Month 9
Change in total volumetric bone mineral density of the radius will be measured by high-resolution peripheral quantitative CT
Baseline to Month 9
Change in total volumetric bone mineral density of the tibia
Time Frame: Baseline to Month 9
Change in total volumetric bone mineral density of the tibia will be measured by high-resolution peripheral quantitative CT
Baseline to Month 9
Change in c-telopeptide of type 1 collagen (CTX)
Time Frame: Baseline to Month 9
Change in c-telopeptide of type 1 collagen (CTX) will be measured by enzyme-linked immunosorbent assay
Baseline to Month 9
Change in procollagen type 1 n-terminal propeptide (P1NP)
Time Frame: Baseline to Month 9
Change in procollagen type 1 n-terminal propeptide (P1NP) will be measured by enzyme-linked immunosorbent assay
Baseline to Month 9
Change in bone-specific alkaline phosphatase (BALP)
Time Frame: Baseline to Month 9
Change in bone-specific alkaline phosphatase (BALP) will be measured by enzyme-linked immunosorbent assay
Baseline to Month 9
Change in osteocalcin
Time Frame: Baseline to Month 9
Change in osteocalcin will be measured by enzyme-linked immunosorbent assay
Baseline to Month 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Denise Houston, PhD, Atrium Health Wake Forest Baptist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00127025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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