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Not yet recruitingPhase 4

The Effect of Semaglutide on Bone Health

The Effect of Semaglutide on Osteoporotic Fractures in Patients With Type 2 Diabetes

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

150

estimated

Study population

Osteoporosis / bone, Type 2 diabetes

Key I/E criterion

Primary endpoint

Lumbar 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 IDNCT07165158
Org study IDKYLLPJ2025-033

Timeline

Milestones

Study first posted2025-09-10actual
Study start2025-09-15estimated
Last update posted2025-09-17actual
Primary completion2026-12-31estimated
Study completion2026-12-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Osteoporosis / boneType 2 diabetes

Eligibility

Who can enroll

Minimum age50 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Type 2 diabetes (according to WHO diagnostic criteria),

2. Age range: 50 to ≦75 years,

3. Glycosylated hemoglobin (HbA1c): 6.5 to ≦9.0%,

4. Bone mineral density (lumbar spine, hip, or femoral neck) T-score < -1, or history of fragility fractures (hip, vertebral, distal forearm, or proximal humerus fractures) within three years before screening,

5. No use of antidiabetic medications in 8 weeks prior to enrollment (excluding metformin).

Exclusion criteria

1. Bone mineral density (lumbar spine, hip, or femoral neck) T-score < -2.5,

2. History of secondary osteoporosis,

3. Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) > 2.5 times the upper limit of the normal reference, or estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73㎡),

4. History of malignant tumors,

5. Received strong anti-osteoporosis medications such as bisphosphonates, denosumab, or teriparatide within the past 2 years,

6. History of pancreatitis or triglyceride levels >5.6 mmol/L;

7. Family history of medullary carcinoma.

Endpoints (1)

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.

Other clinical outcomes

1 endpoint
Primary/protocol endpoint/low confidence

lumbar bone mineral density

Time frame:From enrollment to the end of treatment at 12 months

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.