GA-27
Not yet recruitingPhase NAPostprandial Regulation of Bone Perfusion in Healthy Individuals
Lead sponsor
Asset
Pramlintide
Amylin analog
Listed sites
1
Recruiting sites
-
Estimated enrollment
15
Study population
-
Eligibility highlights
•BMI 18.5-30
Primary endpoint
•Median Ki in the Femur
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
Timeline
Milestones
Assets
Investigational agents
Who can enroll
Inclusion criteria
1. Age 25-50 years.
2. BMI between 18.5-30 kg/m2.
3. Normal gait.
4. Premenopausal (if female).
5. Informed consent.
Exclusion criteria
1. Bone disease incl. confirmed osteopenia.
2. Fracture within the last 6 months at the time of inclusion.
3. Amputation or congenital defect of extremities.
4. HbA1c>41.9 mmol/mol and/or diagnosed type 1 or type 2 diabetes.
5. Any ongoing or prior medication that the investigator evaluates could interfere with the endpoints of the study (e.g. glucocorticoids or other medications that may compromise bone health).
6. Pregnancy or breastfeeding (or plans thereof within the study duration).
7. Not using effective hormonal contraceptives or an intra uterine device within study duration (e.g. oral contraceptives, transdermal patch, vaginal ring, Depo-Provera injections, Nexplanon implant).
8. Ongoing or prior alcohol abuse (defined per ICD-10 classification for alcohol dependence syndrome, F10.21) or daily alcohol intake
9. Use of any illicit substance or narcotics within three months of inclusion, including within study duration.
10. Any physical or psychological condition that the investigator evaluates would interfere with trial participation.
11. Recent (three months prior to inclusion), ongoing or planned weight loss within study duration (weight loss defined as exceeding -5% bodyweight, or intentional hypocaloric dieting)
Endpoints (14)
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
Glycemic / diabetes
3 endpointsMean difference in pramlintide
Time frame:90 minutes.
descriptive
Mean difference in blood glucose
Time frame:90 minutes.
descriptive
Mean difference in C-peptide
Time frame:90 minutes.
descriptive
Other (unclassified)
11 endpointsMedian Ki in the Femur
Time frame:90 minutes
descriptive
Median Ki in the lumbar spine
Time frame:90 minutes
descriptive
Ki in other bones.
Time frame:90 minutes
descriptive
Bone perfusion (K1)
Time frame:90 minutes
descriptive
Bone incorporation fraction (K3/K3+K2)
Time frame:90 minutes.
ratio, improvement
Mean difference in CTX
Time frame:90 minutes.
descriptive
Mean difference in P1NP
Time frame:90 minutes
descriptive
Mean difference in PTH.
Time frame:90 minutes.
descriptive
Mean difference in GIP(1-42)
Time frame:90 minutes.
descriptive
Mean difference in GLP-2(1-33)
Time frame:90 minutes.
descriptive
Mean and max SUV (standardized uptake values)
Time frame:90 minutes.
descriptive
Provenance
Sources
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 6, 2026 snapshot.