Spinal Muscular Atrophy (SMA)NCT07254988
Gut Peptides and Bone Remodeling in Children With Neuromuscular Disorders
A study testing Meal test and GIP + GLP-2 in people with Spinal Muscular Atrophy (SMA) and Cerebral Palsy (CP), run by University of Copenhagen at 1 site in Denmark.
Trial summary
Both GIP and GLP-2 reduce bone resorption (measured as CTX) in healthy adult individuals. In this study, we will investigate whether GIP and GLP-2 reduce CTX in children with spinal muscular atrophy, duchenne muscular dystrophy, or cerebral palsy. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Spinal Muscular Atrophy (SMA), Cerebral Palsy (CP), Duchenne Muscular Dystrophy (DMD)
- What is being tested?
- Meal test and GIP + GLP-2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Mar 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis with Cerebral palsy (CP), Duchenne muscular dystrophy (DMD) or Spinal muscular atrophy (SMA) resulting in the need of a wheelchair
Who cannot join
- Use of anti-resorptive medication
- Confounding illnesses
- Pregnancy
- Allergy towards the components given on the test days
- Hgb<6.5 mmol/L
Trial locations and contacts
1 site in 1 country.
About this study
Both GIP and GLP-2 reduce bone resorption (measured as CTX) in healthy adult individuals. In this study, we will investigate whether GIP and GLP-2 reduce CTX in children with spinal muscular atrophy, duchenne muscular dystrophy, or cerebral palsy.
- Being tested
- Meal test, GIP + GLP-2, Placebo
- Medical subject headings
- Muscular Atrophy, Spinal, Cerebral Palsy, Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal testOther
Ingestion of an oral liquid meal (nutridrink), 3.3 mL/kg body weight.
GIP + GLP-2Other
Subcutaneous GIP + GLP-2 injection (1 mL containing 100 microgram GIP + 1 mL containing 400 microgram GLP-2).
PlaceboOther
Subcutaneous saline injection (2 mL isotonic saline).
| Study group | Role | What they receive |
|---|---|---|
| Meal test | Experimental | Oral liquid meal test Receives: Other: Meal test |
| Glucose dependent insulinotropic polypeptide (GIP) + Glucagon-like-peptide 2 (GLP-2) | Experimental | Subcutaneous co-injection of GIP and GLP-2 Receives: Other: GIP + GLP-2 |
| Placebo | Placebo comparator | Subcutaneous injection of saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTX
Bone resorption measured as carboxy-terminal telopeptide of type I collagen (CTX)
Measured: -10 to 240 minutes
Secondary outcomes (7)
P1NP
Bone formation measured as procollagen type I N-terminal propeptide (P1NP)
Measured: -10 to 240 minutes
PTH
Parathyroid hormone (PTH) measured in plasma
Measured: -10 to 240 minutes
Glucose
Blood glucose measured in plasma
Measured: -10 to 240 minutes
GIP
Glucose-dependent insulinotropic polypeptide (GIP) measured in plasma
Measured: -10 to 240 minutes
GLP-2
Glucagon-like-peptide 2 (GLP-2) measured in plasma
Measured: -10 to 240 minutes
Blood pressure
Measured before blood sampling
Measured: -10 to 240 minutes
Heart rate
Measured before blood sampling
Measured: -10 to 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start24 Mar 2023
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Why it stopped: Terminated since further recruitment proved difficult
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Muscular Atrophy (SMA)Studies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bolette Hartmann, University of Copenhagen
- Investigators
- Mette Marie Rosenkilde, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254988
- Sponsor's protocol ID
- TK-23
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Peptides and Bone Remodeling in Children With Neuromuscular Disorders
- ClinicalTrials.gov ID
- NCT07254988
- Acronym / sponsor ID
- TK-23
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated since further recruitment proved difficult
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Both GIP and GLP-2 reduce bone resorption (measured as CTX) in healthy adult individuals. In this study, we will investigate whether GIP and GLP-2 reduce CTX in children with spinal muscular atrophy, duchenne muscular dystrophy, or cerebral palsy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meal test | Experimental | Other: Meal testOral liquid meal test |
| Glucose dependent insulinotropic polypeptide (GIP) + Glucagon-like-peptide 2 (GLP-2) | Experimental | Other: GIP + GLP-2Subcutaneous co-injection of GIP and GLP-2 |
| Placebo | Placebo comparator | Other: PlaceboSubcutaneous injection of saline |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis with Cerebral palsy (CP), Duchenne muscular dystrophy (DMD) or Spinal muscular atrophy (SMA) resulting in the need of a wheelchair
Key exclusion criteria (5 listed)
- Use of anti-resorptive medication
- Confounding illnesses
- Pregnancy
- Allergy towards the components given on the test days
- Hgb<6.5 mmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal testIngestion of an oral liquid meal (nutridrink), 3.3 mL/kg body weight. | Other | Meal test |
| GIP + GLP-2Subcutaneous GIP + GLP-2 injection (1 mL containing 100 microgram GIP + 1 mL containing 400 microgram GLP-2). | Other | Glucose dependent insulinotropic polypeptide (GIP) + Glucagon-like-peptide 2 (GLP-2) |
| PlaceboSubcutaneous saline injection (2 mL isotonic saline). | Other | Placebo |
Primary outcome
CTX
Time frame: -10 to 240 minutes
Bone resorption measured as carboxy-terminal telopeptide of type I collagen (CTX)
7 secondary outcomes
P1NP
Time frame: -10 to 240 minutes
PTH
Time frame: -10 to 240 minutes
Glucose
Time frame: -10 to 240 minutes
GIP
Time frame: -10 to 240 minutes
GLP-2
Time frame: -10 to 240 minutes
Blood pressure
Time frame: -10 to 240 minutes
Heart rate
Time frame: -10 to 240 minutes
Results and safety
The study was stopped early (reason given: Terminated since further recruitment proved difficult). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Marie Rosenkilde study director
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal test and GIP + GLP-2 in people with Spinal Muscular Atrophy (SMA) and Cerebral Palsy (CP), run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated since further recruitment proved difficult). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTX (time frame: -10 to 240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.