DelfaGLP-1 Atlas

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GLOW

Active not recruitingPhase 4

GLP-1s to Enhance Lasting Optimal Weight

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

—

Enrollment

40

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI 30-37•Age ≥65

Primary endpoints

•Lean mass•Total fat mass•Total hip bone mineral density

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06861439
Org study IDIRB00127025

Timeline

Milestones

Study first posted2025-03-06actual
Study start2025-07-07actual
Last update posted2025-10-28actual
Primary completion2026-09-30estimated
Study completion2026-12-31estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age65 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
8
Weight & body composition
6
Other (unclassified)
4
Heart failure
1

Weight & body composition

6 endpoints
Primary/protocol endpoint

Change in total body lean mass

Time frame:Baseline to Month 9

Lean mass

change from baseline, improvement

Primary/protocol endpoint

Change in appendicular lean mass

Time frame:Baseline to Month 9

Lean mass

change from baseline, improvement

Primary/protocol endpoint

Change in total body fat mass

Time frame:Baseline to Month 9

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change in thigh intramuscular fat tissue

Time frame:Baseline to Month 9

change from baseline, improvement

Secondary/protocol endpoint

Change in thigh muscle volume

Time frame:Baseline to Month 9

change from baseline, improvement

Secondary/protocol endpoint

Change in total skeletal muscle mass

Time frame:Baseline to Month 9

Lean mass

change from baseline, improvement

Heart failure

1 endpoint
Primary/protocol endpoint/low confidence

Change in 400 meter walk time

Time frame:Baseline to Month 9

change from baseline, improvement

Other clinical outcomes

8 endpoints
Primary/protocol endpoint/low confidence

Change in total hip bone mineral density

Time frame:Baseline to Month 9

change from baseline, descriptive

Primary/protocol endpoint

Change in lumbar spine bone mineral density

Time frame:Baseline to Month 9

change from baseline, improvement

Primary/protocol endpoint

Change in lower extremity physical performance score

Time frame:Baseline to Month 9

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in leg strength

Time frame:Baseline to Month 9

change from baseline, improvement

Secondary/protocol endpoint

Change in total volumetric bone mineral density of the hip

Time frame:Baseline to Month 9

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in hip bone strength

Time frame:Baseline to Month 9

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in total volumetric bone mineral density of the radius

Time frame:Baseline to Month 9

change from baseline, improvement

Secondary/protocol endpoint

Change in total volumetric bone mineral density of the tibia

Time frame:Baseline to Month 9

change from baseline, improvement

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

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

Time frame:Baseline to Month 9

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline to Month 9

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in bone-specific alkaline phosphatase (BALP)

Time frame:Baseline to Month 9

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in osteocalcin

Time frame:Baseline to Month 9

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.