PRESERVE-HMB

Not yet recruitingPhase 2

HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide

Preserving the Metabolic Engine: Effects of HMB Supplementation on Skeletal Muscle Structure and Function During Semaglutide-Associated Weight Loss in Older Adults

Lead sponsor

Vanderbilt University Medical Center

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight, Older Adults, Sarcopenia / muscle, Type 2 diabetes

Eligibility highlights

•BMI ≥27•HbA1c ≥6.5%•Age 65-85

Primary endpoint

•Appendicular Lean Mass

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07760948

Org study ID261081

Secondary ID9-26-ICTS-1434American Diabetes Association

Timeline

Milestones

Study first posted2026-08-12actual

Last update posted2026-08-28actual

Study start2026-12-01estimated

Primary completion2029-11-30estimated

Study completion2030-11estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightOlder AdultsSarcopenia / muscleType 2 diabetes

Who can enroll

Minimum age65 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age 65 to 85 years, inclusive.

•Type 2 diabetes mellitus, defined by HbA1c at or above 6.5% or current use of antihyperglycemic medication.

•Body mass index at or above 27 kg/m2.

•Newly initiating semaglutide as standard clinical care under the direction of a treating clinician.

•Able to walk 400 meters without assistance; use of a cane is permitted.

•Able to understand and provide legally effective informed consent.

•English speaking for the initial study because the consent documents, questionnaires, study-product instructions, safety instructions, and procedure-specific materials are available only in English.

Exclusion criteria

•Estimated glomerular filtration rate below 45 mL/min/1.73 m2.

•Use of HMB, creatine, or high-dose whey protein supplements within the previous 3 months.

•Weight change greater than 5% during the previous 3 months.

•Recent fracture within the previous 6 months.

•Neuromuscular disease, including Parkinson disease, or another condition that would interfere with study outcomes or safe participation.

•Chronic corticosteroid use.

•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.

•History of pancreatitis.

•Smoking more than 7 cigarettes per day.

•Previous malabsorptive or restrictive intestinal surgery or a malabsorptive syndrome.

•Pregnancy or breastfeeding.

•Recent history of neoplasia within the previous 5 years, as defined by the protocol.

•Other active inflammatory conditions or neuromuscular disorders that could interfere with study outcomes or safety.

•Serum 25-hydroxyvitamin D below 15 ng/mL.

•Any medical, functional, laboratory, medication-related, or safety condition that the investigator determines makes study participation unsafe or prevents completion of essential procedures.

Endpoints (23)

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 (unclassified)

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Other clinical outcomes

Weight & body composition

4 endpoints

Primary/protocol endpoint

Change in Appendicular Lean Mass

Time frame:Baseline to month 6

change from baseline, improvement

Secondary/protocol endpoint

Title Change in Body Weight

Time frame:Baseline to month 6

change from baseline, improvement

Secondary/protocol endpoint

Change in Total Fat Mass

Time frame:Baseline to month 6

change from baseline, improvement

Secondary/protocol endpoint

Title Change in Visceral Adipose Tissue

Time frame:Baseline to month 6

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in Glycated Hemoglobin

Time frame:Time Frame Baseline to month 6

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting Plasma Glucose

Time frame:Baseline to month 6

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Incidence of Adverse Events

Time frame:From first study-product dose through completion of month-6 follow-up or resolution/stabilization of ongoing events

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Study-Product Adherence

Time frame:Through month 6

descriptive

Other (unclassified)

15 endpoints

Secondary/protocol endpoint/low confidence

Change in Bone Mineral Density

Time frame:Baseline to month 6

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Trabecular Bone Score

Time frame:Baseline to month 6

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Resting Metabolic Rate

Time frame:Baseline to month 6

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Handgrip Strength

Time frame:Baseline, month 3, and month 6

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Title Change in Lower-Extremity Strength or Torque

Time frame:Baseline to month 6

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Title Change in Short Physical Performance Battery Score

Time frame:Baseline, month 3, and month 6

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Six-Minute Walk Distance

Time frame:Baseline, month 3, and month 6

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Gait Measures

Time frame:Baseline, month 3, and month 6

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Physical Activity

Time frame:Protocol-defined monitoring periods at baseline or month 3 and month 6

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Whole-Body CT-Derived Muscle Volume and Composition

Time frame:Baseline to month 6

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Total Body Creatine Pool Size

Time frame:Baseline to month 6

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Myofibrillar Protein Synthesis

Time frame:Baseline and month 6 Aim 3 metabolic visits

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Muscle Protein Breakdown

Time frame:Baseline and month 6 Aim 3 metabolic visits

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Net Muscle Protein Balance

Time frame:Baseline and month 6 Aim 3 metabolic visits

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Muscle Fiber Size and Type

Time frame:Baseline to month 6

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.