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Trial · Interventional

Active, not recruitingPhase 4Registry data

GLP-1s to Enhance Lasting Optimal Weight

Short name GLOW

NCTNCT06861439 (opens ClinicalTrials.gov in a new tab)Other idIRB00127025
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
40 participants (actual)
Sponsor
Wake Forest University Health Sciences · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
7 Jul 2025
Primary completion
30 Oct 2027 (estimated)
Completion
31 Dec 2027 (estimated)
First posted
6 Mar 2025
Last update posted
2 Oct 2026
Conditions
Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028
  1. Ph 4

    GLOW

    NCT06861439

    7 Jul 2025 to est. 31 Dec 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug

Arms1

  • Experimental

    Tirzepatide

    Tirzepatide injection once weekly for 9 months

Primary outcomes18

Outcomes the sponsor listed as primary.

  1. Change in total body lean mass

    Time frame · Baseline to Month 9

    Registry description

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

  2. Change in total body lean mass

    Time frame · Month 9 to Month 21

    Registry description

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

  3. Change in appendicular lean mass

    Time frame · Baseline to Month 9

    Registry description

    Change in appendicular lean mass will be measured by DXA scan

  4. Change in appendicular lean mass

    Time frame · Month 9 to Month 21

    Registry description

    Change in appendicular lean mass will be measured by DXA scan

  5. Change in total body fat mass

    Time frame · Baseline to Month 9

    Registry description

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

  6. Change in total body fat mass

    Time frame · Month 9 to Month 21

    Registry description

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

  7. Change in total hip bone mineral density

    Time frame · Baseline to Month 9

    Registry description

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

  8. Change in total hip bone mineral density

    Time frame · Month 9 to Month 21

    Registry description

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

  9. Change in lumbar spine bone mineral density

    Time frame · Baseline to Month 9

    Registry description

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

  10. Change in lumbar spine bone mineral density

    Time frame · Month 9 to Month 21

    Registry description

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

  11. Change in 400 meter walk time

    Time frame · Baseline to Month 9

    Registry description

    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.

  12. Change in 400 meter walk time

    Time frame · Month 9 to Month 21

    Registry description

    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.

  13. Change in lower extremity physical performance score

    Time frame · Baseline to Month 9

    Registry description

    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.

  14. Change in lower extremity physical performance score

    Time frame · Month 9 to Month 21

    Registry description

    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.

  15. Change in leg strength

    Time frame · Baseline to Month 9

    Registry description

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

  16. Change in grip strength

    Time frame · Baseline to Month 9

    Registry description

    Change in grip strength will be assessed using the Jamar hand-held dynamometer

  17. Change in grip strength

    Time frame · Month 9 to Month 21

    Registry description

    Change in grip strength will be assessed using the Jamar hand-held dynamometer

  18. Change in leg strength

    Time frame · Month 9 to Month 21

    Registry description

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

Secondary outcomes(11)

  1. Change in thigh intramuscular fat tissue

    Time frame · Baseline to Month 9

    Registry description

    Change in thigh intramuscular fat tissue will be measured by CT scan

  2. Change in thigh muscle volume

    Time frame · Baseline to Month 9

    Registry description

    Change in thigh muscle volume will be measured by CT scan

  3. Change in total skeletal muscle mass

    Time frame · Baseline to Month 9

    Registry description

    Change in total skeletal muscle mass will be assessed by D3 creatine

  4. Change in total volumetric bone mineral density of the hip

    Time frame · Baseline to Month 9

    Registry description

    Change in total volumetric bone mineral density of the hip will be measured by CT scan

  5. Change in hip bone strength

    Time frame · Baseline to Month 9

    Registry description

    Change in hip bone strength will be measured by CT scan

  6. Change in total volumetric bone mineral density of the radius

    Time frame · Baseline to Month 9

    Registry description

    Change in total volumetric bone mineral density of the radius will be measured by high-resolution peripheral quantitative CT

  7. Change in total volumetric bone mineral density of the tibia

    Time frame · Baseline to Month 9

    Registry description

    Change in total volumetric bone mineral density of the tibia will be measured by high-resolution peripheral quantitative CT

  8. Change in c-telopeptide of type 1 collagen (CTX)

    Time frame · Baseline to Month 9

    Registry description

    Change in c-telopeptide of type 1 collagen (CTX) will be measured by enzyme-linked immunosorbent assay

  9. Change in procollagen type 1 n-terminal propeptide (P1NP)

    Time frame · Baseline to Month 9

    Registry description

    Change in procollagen type 1 n-terminal propeptide (P1NP) will be measured by enzyme-linked immunosorbent assay

  10. Change in bone-specific alkaline phosphatase (BALP)

    Time frame · Baseline to Month 9

    Registry description

    Change in bone-specific alkaline phosphatase (BALP) will be measured by enzyme-linked immunosorbent assay

  11. Change in osteocalcin

    Time frame · Baseline to Month 9

    Registry description

    Change in osteocalcin will be measured by enzyme-linked immunosorbent assay

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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