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Popular diabetes drug semaglutide under scrutiny for bone effects

NCT ID NCT07165158

Disease control Sponsor: The First Affiliated Hospital of Xiamen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether semaglutide (a diabetes drug that lowers blood sugar and helps with weight loss) affects bone density and fracture risk in people with type 2 diabetes. About 150 adults aged 50–75 will get either semaglutide plus metformin or metformin alone for 12 months. Researchers will then compare bone density, fracture rates, and bone health markers between the two groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
semaglutide combined with metformin
What this could lead to
If it works, this could show that semaglutide is safe for bones and may even help prevent fractures in people with type 2 diabetes.
What could go wrong
This is a small, early-phase trial (150 people) that hasn't started yet. The results may not apply to everyone, and weight loss from semaglutide could actually weaken bones.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

osteoporosis Osteoporotic Fractures type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoporosis Osteoporosis fracture T2DM

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, China

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