NCT07679516

Brief Summary

The goal of this clinical trial is to learn whether certain natural hormones - Glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-2, (GLP-2), and amylin - affect blood flow to the bones.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
22mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026May 2028

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

July 19, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

July 9, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

June 25, 2026

Last Update Submit

July 7, 2026

Conditions

Healthy Adult ParticipantsBone PhysiologyBone Blood Flow RegulationPeptide Hormones

Outcome Measures

Primary Outcomes (1)

  • Median Ki in the Femur

    Kinetic modelling

    90 minutes

Secondary Outcomes (12)

  • Median Ki in the lumbar spine

    90 minutes

  • Ki in other bones.

    90 minutes

  • Bone perfusion (K1)

    90 minutes

  • Bone incorporation fraction (K3/K3+K2)

    90 minutes.

  • Mean difference in CTX

    90 minutes.

  • +7 more secondary outcomes

Other Outcomes (1)

  • Mean and max SUV (standardized uptake values)

    90 minutes.

Study Arms (4)

Isotonic saline

PLACEBO COMPARATOR

Saltwater infusion in a peripheral vein

Other: isotonic saline infusion

GIP(1-42)

ACTIVE COMPARATOR

Infusion of the native hormone GIP(1-42) in a peripheral vein

Other: Infusion of GIP(1-42)

GLP-2(1-33)

ACTIVE COMPARATOR

Infusion of the native hormone GLP-2(1-33) in a peripheral vein

Other: Infusion of GLP-2(1-33)

Pramlintide

ACTIVE COMPARATOR

Infusion of pramlintide (amylin analogue) in a peripheral vein

Other: Infusion of pramlintide

Interventions

isotonic saline infusionOTHER

Placebo infusion for comparison of active hormone

Isotonic saline
Infusion of GIP(1-42)OTHER

Study tool

GIP(1-42)
Infusion of GLP-2(1-33)OTHER

Study tool

GLP-2(1-33)
Infusion of pramlintideOTHER

Study tool

Pramlintide

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 25-50 years.
  • BMI between 18.5-30 kg/m2.
  • Normal gait.
  • Premenopausal (if female).
  • Informed consent.

You may not qualify if:

  • Bone disease incl. confirmed osteopenia.
  • Amputation or congenital defect of extremities.
  • HbA1c\>41.9 mmol/mol and/or diagnosed type 1 or type 2 diabetes.
  • 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).
  • Pregnancy or breastfeeding (or plans thereof within the study duration).
  • 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).
  • Ongoing or prior alcohol abuse (defined per ICD-10 classification for alcohol dependence syndrome, F10.21) or daily alcohol intake
  • Any physical or psychological condition that the investigator evaluates would interfere with trial participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Central Study Contacts

Lærke S Gasbjerg, MD, PhD

CONTACT

+4525346894lsg@sund.ku.dk

Mette G Thomsen, Cand.Scient

CONTACT

+4560624598mette.grodal@sund.ku.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

July 19, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

July 9, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Will share upon request.

Locations

DK(1)