ObesityLIRAPNCT03520062
The Effect of Liraglutide on Pancreatic Hormones and Its Size
A study testing Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml in people with Obesity, run by Nicolai Jacob Wewer Albrechtsen at 1 site in Denmark.
Trial summary
Glucagon-like peptide-1 (GLP-1) is a gastrointestinal hormone used to treat type 2 diabetes and severe overweight (Liraglutide).The two pancreas enzymes: amylase and lipase are slightly elevated in GLP-1 treated compared with placebo-treated individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2017to 1 Jan 2020
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 26 og < 50 kg/m2
Who cannot join
- Abdominal Diameter >60cm type 1 or type 2 diabetes Heart Failure or Disease Statins Kidney or Liver disease Thyroid Disease Inflammatory Bowel Disease Gastroparesis Cancer Lung disease Psychiatric disease Gastric Bypass operation Previous pancreatitis Increased alcoholic consumption Familiar incidence of multiple endocrine neoplasia Previous treatment with GLP-1 (incretin) based medicine Pacemaker or other non-MR-compatible devices
Trial locations and contacts
1 site in 1 country.
About this study
Glucagon-like peptide-1 (GLP-1) is a gastrointestinal hormone used to treat type 2 diabetes and severe overweight (Liraglutide).The two pancreas enzymes: amylase and lipase are slightly elevated in GLP-1 treated compared with placebo-treated individuals. Increased levels of these two enzymes (amylase and lipase) are associated with acute inflammation of the pancreas (acute pancreatitis). In humans treated with GLP-1 (receptor agonist) there have not been found an increased risk of acute pancreatitis.
Animal and cell studies have shown that the increased levels of amylase and lipase in the blood are not due to an inflammatory state but adaptive changes (volume increase) of the pancreas.
Read more
The investigators (professor Jens Juul Holst, professor Sten Madsbad) want to investigate whether the increased levels of amylase and lipase in the blood of individuals treated with the GLP-1 analogue Saxenda are due adaptive changes of the pancreas. This will be achieved by measuring amylase and lipase before, during and after treatment with a GLP-1 receptor agonist, and at the same time use advanced scanning equipment (PET-MR) from the Clinical Physiological and Nuclear Medical Department at Rigshospitalet, which can determine any volumetric changes in the pancreas with high reproducibility.
The scan will be centered on the pancreas, other organs are not evaluated why the study is not designed to detect any malignant findings in the pancreas or other organs.
- Conditions
- Obesity
- Being tested
- Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
- Keywords
- Amylase, Lipase, GLP-1
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3MlDrug
Treatment with Liraglutide (3.0mg per day) for ~6 weeks
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 Receptor Agonist (Liraglutide) | Experimental | 3.0mg daily dose Receives: Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric Changes of the Pancreas
Measurements of the pancreas volumen using magnetic resonance imaging-positron emission tomography based technology
Measured: 6 weeks
Secondary outcomes (7)
Changes in Plasma Concentrations of Pancreatic Amylase and Lipase
Measured: 6 weeks
Changes in body weight
Measured: 6 weeks
Changes in glycemic index
Measured: 6 weeks
Plasma concentrations of glucagon, insulin and citrullin
Measured: 6 weeks
Plasma concentrations of the drug
Measured: 6 weeks
Other MR based changes in the pancreas (edema, cellularity and structural changes)
Measured: 6 weeks
Uptake of fluorothymidine tracer in the pancreas measured by PET
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start15 Aug 2017
- Primary completion30 Apr 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolai Jacob Wewer Albrechtsen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Nicolai Jacob Wewer Albrechtsen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520062
- Sponsor's protocol ID
- LIRAP
- Acronym
- LIRAP
- Status last verified
- Mar 2020
- First submitted
- 24 Apr 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have yet not decided to share IPD as this also would require approval from the ethical and data approval comite
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Liraglutide on Pancreatic Hormones and Its Size
- ClinicalTrials.gov ID
- NCT03520062
- Acronym / sponsor ID
- LIRAP / LIRAP
- Conditions
- Obesity
- Keywords
- Amylase, Lipase, GLP-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Nicolai Jacob Wewer AlbrechtsenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 9 May 2018 (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.
Glucagon-like peptide-1 (GLP-1) is a gastrointestinal hormone used to treat type 2 diabetes and severe overweight (Liraglutide).The two pancreas enzymes: amylase and lipase are slightly elevated in GLP-1 treated compared with placebo-treated individuals. Increased levels of these two enzymes (amylase and lipase) are associated with acute inflammation of the pancreas (acute pancreatitis). In humans treated with GLP-1 (receptor agonist) there have not been found an increased risk of acute pancreatitis.
Animal and cell studies have shown that the increased levels of amylase and lipase in the blood are not due to an inflammatory state but adaptive changes (volume increase) of the pancreas.
The investigators (professor Jens Juul Holst, professor Sten Madsbad) want to investigate whether the increased levels of amylase and lipase in the blood of individuals treated with the GLP-1 analogue Saxenda are due adaptive changes of the pancreas. This will be achieved by measuring amylase and lipase before, during and after treatment with a GLP-1 receptor agonist, and at the same time use advanced scanning equipment (PET-MR) from the Clinical Physiological and Nuclear Medical Department at Rigshospitalet, which can determine any volumetric changes in the pancreas with high reproducibility.
The scan will be centered on the pancreas, other organs are not evaluated why the study is not designed to detect any malignant findings in the pancreas or other organs.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLP-1 Receptor Agonist (Liraglutide) | Experimental | Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml3.0mg daily dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI ≥ 26 og < 50 kg/m2
Key exclusion criteria (1 listed)
- Abdominal Diameter >60cm type 1 or type 2 diabetes Heart Failure or Disease Statins Kidney or Liver disease Thyroid Disease Inflammatory Bowel Disease Gastroparesis Cancer Lung disease Psychiatric disease Gastric Bypass operation Previous pancreatitis Increased alcoholic consumption Familiar incidence of multiple endocrine neoplasia Previous treatment with GLP-1 (incretin) based medicine Pacemaker or other non-MR-compatible devices
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 |
|---|---|---|
| Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3MlTreatment with Liraglutide (3.0mg per day) for ~6 weeks | Drug | GLP-1 Receptor Agonist (Liraglutide) |
Primary outcome
Volumetric Changes of the Pancreas
Time frame: 6 weeks
Measurements of the pancreas volumen using magnetic resonance imaging-positron emission tomography based technology
7 secondary outcomes
Changes in Plasma Concentrations of Pancreatic Amylase and Lipase
Time frame: 6 weeks
Changes in body weight
Time frame: 6 weeks
Changes in glycemic index
Time frame: 6 weeks
Plasma concentrations of glucagon, insulin and citrullin
Time frame: 6 weeks
Plasma concentrations of the drug
Time frame: 6 weeks
Other MR based changes in the pancreas (edema, cellularity and structural changes)
Time frame: 6 weeks
Uptake of fluorothymidine tracer in the pancreas measured by PET
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: Undecided. We have yet not decided to share IPD as this also would require approval from the ethical and data approval comite
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml in people with Obesity, run by Nicolai Jacob Wewer Albrechtsen 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 1 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: finished, as of the sponsor's last update on 24 Mar 2020. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Volumetric Changes of the Pancreas (time frame: 6 weeks). 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 24 Mar 2020.