ObesityPhase 4GLOWNCT06861439
GLP-1s to Enhance Lasting Optimal Weight
A Phase 4 study testing Tirzepatide in people with Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 31Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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).
- Conditions
- Obesity
- Being tested
- Tirzepatide
- Keywords
- Weight Loss, Muscle Loss, Physical Disability, Bone Density, Older Adults
- Medical subject headings
- Obesity, Weight Loss, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called Zepbound
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.
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Tirzepatide injection once weekly for 9 months Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total body lean mass
Change in total body lean mass will be measured by DXA scan
Measured: Baseline to Month 9
Change in total body lean mass
Change in total body lean mass will be measured by DXA scan
Measured: Month 9 to Month 21
Change in appendicular lean mass
Change in appendicular lean mass will be measured by DXA scan
Measured: Baseline to Month 9
Change in appendicular lean mass
Change in appendicular lean mass will be measured by DXA scan
Measured: Month 9 to Month 21
Change in total body fat mass
Change in total body fat mass will be measured by DXA scan
Measured: Baseline to Month 9
Change in total body fat mass
Change in total body fat mass will be measured by DXA scan
Measured: Month 9 to Month 21
Change in total hip bone mineral density
Change in total hip bone mineral density will be measured by DXA scan
Measured: Baseline to Month 9
Change in total hip bone mineral density
Change in total hip bone mineral density will be measured by DXA scan
Measured: Month 9 to Month 21
Change in lumbar spine bone mineral density
Change in lumbar spine bone mineral density will be measured by DXA scan
Measured: Baseline to Month 9
Change in lumbar spine bone mineral density
Change in lumbar spine bone mineral density will be measured by DXA scan
Measured: Month 9 to Month 21
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.
Measured: 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.
Measured: Month 9 to Month 21
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.
Measured: 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.
Measured: Month 9 to Month 21
Change in leg strength
Change in leg extensor strength will be assessed using the Keiser AIR300 Leg Press System.
Measured: Baseline to Month 9
Change in grip strength
Change in grip strength will be assessed using the Jamar hand-held dynamometer
Measured: Baseline to Month 9
Change in grip strength
Change in grip strength will be assessed using the Jamar hand-held dynamometer
Measured: Month 9 to Month 21
Change in leg strength
Change in leg extensor strength will be assessed using the Keiser AIR300 Leg Press System.
Measured: Month 9 to Month 21
Secondary outcomes (11)
Change in thigh intramuscular fat tissue
Change in thigh intramuscular fat tissue will be measured by CT scan
Measured: Baseline to Month 9
Change in thigh muscle volume
Change in thigh muscle volume will be measured by CT scan
Measured: Baseline to Month 9
Change in total skeletal muscle mass
Change in total skeletal muscle mass will be assessed by D3 creatine
Measured: Baseline to Month 9
Change in total volumetric bone mineral density of the hip
Change in total volumetric bone mineral density of the hip will be measured by CT scan
Measured: Baseline to Month 9
Change in hip bone strength
Change in hip bone strength will be measured by CT scan
Measured: Baseline to Month 9
Change in total volumetric bone mineral density of the radius
Change in total volumetric bone mineral density of the radius will be measured by high-resolution peripheral quantitative CT
Measured: Baseline to Month 9
Change in total volumetric bone mineral density of the tibia
Change in total volumetric bone mineral density of the tibia will be measured by high-resolution peripheral quantitative CT
Measured: Baseline to Month 9
Change in c-telopeptide of type 1 collagen (CTX)
Change in c-telopeptide of type 1 collagen (CTX) will be measured by enzyme-linked immunosorbent assay
Measured: Baseline to Month 9
Change in procollagen type 1 n-terminal propeptide (P1NP)
Change in procollagen type 1 n-terminal propeptide (P1NP) will be measured by enzyme-linked immunosorbent assay
Measured: Baseline to Month 9
Change in bone-specific alkaline phosphatase (BALP)
Change in bone-specific alkaline phosphatase (BALP) will be measured by enzyme-linked immunosorbent assay
Measured: Baseline to Month 9
Change in osteocalcin
Change in osteocalcin will be measured by enzyme-linked immunosorbent assay
Measured: Baseline to Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start7 Jul 2025
- Primary completion30 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denise Houston, PhD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861439
- Sponsor's protocol ID
- IRB00127025
- Acronym
- GLOW
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tirzepatide on Fat-Free Mass, Bone and Physical Function in Older Adults - a Pilot Study
- ClinicalTrials.gov ID
- NCT06861439
- Acronym / sponsor ID
- GLOW / IRB00127025
- Conditions
- Obesity
- Keywords
- Weight Loss, Muscle Loss, Physical Disability, Bone Density, Older Adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: TirzepatideTirzepatide injection once weekly for 9 months |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (31 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: ZepboundTirzepatide 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. | Drug | Tirzepatide |
Primary outcome
Change in total body lean mass
Time frame: Baseline to Month 9
Change in total body lean mass will be measured by DXA scan
Change in total body lean mass
Time frame: Month 9 to Month 21
Change in total body lean mass will be measured by DXA scan
Change in appendicular lean mass
Time frame: Baseline to Month 9
Change in appendicular lean mass will be measured by DXA scan
Change in appendicular lean mass
Time frame: Month 9 to Month 21
Change in appendicular lean mass will be measured by DXA scan
Change in total body fat mass
Time frame: Baseline to Month 9
Change in total body fat mass will be measured by DXA scan
Change in total body fat mass
Time frame: Month 9 to Month 21
Change in total body fat mass will be measured by DXA scan
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
Change in total hip bone mineral density
Time frame: Month 9 to Month 21
Change in total hip bone mineral density will be measured by DXA scan
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
Change in lumbar spine bone mineral density
Time frame: Month 9 to Month 21
Change in lumbar spine bone mineral density will be measured by DXA scan
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.
Change in 400 meter walk time
Time frame: Month 9 to Month 21
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.
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.
Change in lower extremity physical performance score
Time frame: Month 9 to Month 21
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.
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.
Change in grip strength
Time frame: Baseline to Month 9
Change in grip strength will be assessed using the Jamar hand-held dynamometer
Change in grip strength
Time frame: Month 9 to Month 21
Change in grip strength will be assessed using the Jamar hand-held dynamometer
Change in leg strength
Time frame: Month 9 to Month 21
Change in leg extensor strength will be assessed using the Keiser AIR300 Leg Press System.
11 secondary outcomes
Change in thigh intramuscular fat tissue
Time frame: Baseline to Month 9
Change in thigh muscle volume
Time frame: Baseline to Month 9
Change in total skeletal muscle mass
Time frame: Baseline to Month 9
Change in total volumetric bone mineral density of the hip
Time frame: Baseline to Month 9
Change in hip bone strength
Time frame: 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 tibia
Time frame: Baseline to Month 9
Change in c-telopeptide of type 1 collagen (CTX)
Time frame: Baseline to Month 9
Change in procollagen type 1 n-terminal propeptide (P1NP)
Time frame: Baseline to Month 9
Change in bone-specific alkaline phosphatase (BALP)
Time frame: Baseline to Month 9
Change in osteocalcin
Time frame: Baseline to Month 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Houston, PhD principal investigator
Atrium Health Wake Forest Baptist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirzepatide in people with Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total body lean mass (time frame: Baseline to Month 9). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.