DelfaGLP-1 Atlas

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Active not recruitingPhase 2

The Effect of Oral Semaglutide on Bone Turnover in Patients With T2D: a Randomized Placebo-controlled Clinical Trial

The Effect of Oral Semaglutide on Bone Turnover in Patients With Type 2 Diabetes: a Randomized Placebo-controlled Clinical Trial - (SOBER II)

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

64

estimated

Study population

Osteoporosis / bone, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Procollagen type 1 N-terminal propeptide (P1NP)

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 IDNCT06050577
Org study IDEU CT: 2023-505959-45-00

Timeline

Milestones

Study first posted2023-09-22actual
Study start2024-06-07actual
Primary completion2026-01-15actual
Last update posted2026-02-09actual
Study completion2027-01-15estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Osteoporosis / boneType 2 diabetes

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes and glycosylated haemoglobin (HbA1C) of 48-91 mmol/mol (6.5-10.5%) and
•T-score <-1 in hip or lower back, assessed by DXA scan and / or
•Low-energy fracture within the last 3 years

Exclusion criteria

•T-score <-2.5 in hip or lower back, assessed by DXA scan, although these individuals may be included if they are not candidates for conventional osteoporosis therapy, e.g., due to allergies and renal impairment, or if they prefer to participate in the trial.
•Type 1 diabetes mellitus
•Severe NPDR (non-proliferative diabetic retinopathy) or PDR (proliferative diabetic retinopathy) assessed within the last year. If a recent assessment is unavailable, a new retinal photo test will be performed.
•Congestive heart failure (NYHA Class IV)
•Primary hyperparathyroidism
•Vitamin D deficiency (<25 nM) (re-test after substitution acceptable)
•Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR <30) or liver dysfunction (baseline phosphatase higher than twice upper limit (105 U/L)), rheumatism, celiac disease, hypogonadism, severe COPD, hypopituitarism, Cushing's disease
•Clinically significant concomitant diseases or disorders (e.g., cancer) or clinically significant abnormal values in laboratory screening tests, including increased Choriogonadotropin (hCG) in women.
•History of gastrointestinal surgery (except uncomplicated surgical procedures such as hernia surgery and appendectomy)
•Antiresorptive or bone anabolic drugs for the last 12 months
•Use of anabolic steroids in the previous year
•Use of GLP-1Ras within 90 days
•Stable therapy with DPP4 inhibitors (unless the patient is willing to discontinue the treatment)
•History of pancreatitis
•Allergy or hypersensitivity to the active substance or to any of the ingredients
•Inability to give informed consent
•Previous bariatric surgery
•BMI <20 kg/m2 or BMI>37 kg/m2

Endpoints (20)

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
13
Weight & body composition
4
Other (unclassified)
2
Glycemic / diabetes
1

Weight & body composition

4 endpoints
Secondary/protocol endpoint

Bone mineral density (BMD)

Time frame:Baseline and 52 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Fat tissue distribution

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Lean tissue distribution

Time frame:Baseline and 52 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Body mass index (BMI)

Time frame:Baseline and 52 weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Glycosylated haemoglobin (HbA1C)

Time frame:Baseline and 52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other clinical outcomes

13 endpoints
Secondary/protocol endpoint

Collagen 1 cross link C-terminal telopeptide (CTX)

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Bone specific alkaline phosphatase (BALP)

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Estimated bone strength

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Total volumetric BMD

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Trabecular volumetric BMD

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Cortical volumetric BMD

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Bone volume

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Trabecular thickness

Time frame:Baseline and 52 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Cortical thickness

Time frame:Baseline and 52 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Cortical porosity

Time frame:Baseline and 52 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Bone formation rate

Time frame:52 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Physical activity

Time frame:Baseline and 52 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Osteogenic potential

Time frame:52 weeks

change from baseline, descriptive

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Procollagen type 1 N-terminal propeptide (P1NP)

Time frame:Baseline and 52 weeks

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Osteocalcin

Time frame:Baseline and 52 weeks

change from baseline, descriptive

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.