OsteoarthritisPhase 4IM-LOSEIT-IINCT02928679
Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance
A Phase 4 study testing Liraglutide 3 mg (Saxenda) in people with Osteoarthritis and Obesity, run by Henrik Gudbergsen at 1 site in Denmark.
Trial summary
This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Osteoarthritis, Obesity
- What is being tested?
- Liraglutide 3 mg (Saxenda)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to 20 Mar 2019
- Phase
- Phase 4
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Same as parent trial (NCT02905864)
- Further Exclusion Criteria:
- Same as parent trial (NCT02905864)
- Usual exclusion criteria for MRI (i.e. pacemakers etc.)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital
Frederiksberg, Capital Region, 2000
About this study
Official title: Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis Following Liraglutide Treatment, Investigating the Impact on Inflammation
This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which patients will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.
This substudy aims to investigate the impact of, and subsequent change of, joint inflammation, articular cartilage composition, overall knee morphology, and clinical symptoms, in obese patients with knee osteoarthritis following a randomisation to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.
- Conditions
- Osteoarthritis, Obesity
- Being tested
- Liraglutide 3 mg (Saxenda), Liraglutide 3 mg placebo
- Keywords
- Magnetic resonance imaging, Dynamic contrast enhanced MRI, Liraglutide 3 mg, Liraglutide, Obesity, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide 3 mg (Saxenda)Drug
Liraglutide 3 mg placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide 3 mg | Experimental | Arm description: Subjects will be up titrated to liraglutide 3 mg QD and stay on that dose for the remainder of the 52-week drug intervention period.
Drug: Liraglutide 3 mg QD administered in a 6 mg/mL, 3 mL pen for subcutaneous injection.
Dose escalation scheme: Initial dosage of 0.6 mg per day, escalated bi-weekly by 0.6 mg to 3 mg per day over a total of 8 weeks. Receives: Drug: Liraglutide 3 mg (Saxenda) |
| Liraglutide 3 mg placebo | Placebo comparator | Arm description: Subjects will be up titrated to liraglutide 3 mg placebo QD and stay on that dose for the remainder of the 52-week drug intervention period.
Drug: Liraglutide 3 mg placebo QD administered in a 6 mg/mL drug equivalent volumes, 3 mL pen for subcutaneous injection.
Dose escalation scheme: Initial dosage of a 0.6 mg drug equivalent volume per day, escalated bi-weekly by an 0.6 mg drug equivalent volume per day to a 3 mg drug equivalent volume per day over a total of 8 weeks. Receives: Drug: Liraglutide 3 mg placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the degree of inflammation in the knee-joint (DCE-MRI)
Change will be assessed via a dynamic contrast enhanced MRI evaluation of corpus hoffa (Ballegaard C et al. and Riis RG et al.)
Measured: Week 0 to 52
Secondary outcomes (4)
Change in the degree of inflammation in the knee-joint (CE-MRI)
Change will be assessed via a static contrast enhanced MRI evaluation of the level of synovitis in the knee-joint (11 sites scored 0-2, ad modum Guermazi et al.)
Measured: Week 0 to 52
Change in the degree of inflammation in the knee-joint (MRI)
Change will be assessed via a conventional MRI evaluation of the level of synovitis and effusion (combined) in the knee-joint (MOAKS)
Measured: Week 0 to 52
Change in cartilage composition
Change will be assessed via T2-maps of cartilage in the weight-bearing parts of the knee-joint (ROI)
Measured: Week 0 to 52
Change in bone marrow lesions
Change will be assessed via the MRI knee scoring system MOAKS; BML sum-score
Measured: Week 0 to 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion20 Feb 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henrik Gudbergsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henrik Gudbergsen, Parker Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928679
- Sponsor's protocol ID
- 137.05
- Acronym
- IM-LOSEIT-II
- Status last verified
- Mar 2019
- First submitted
- 7 Oct 2016
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis Following Liraglutide Treatment, Investigating the Impact on Inflammation
- ClinicalTrials.gov ID
- NCT02928679
- Acronym / sponsor ID
- IM-LOSEIT-II / 137.05
- Conditions
- Osteoarthritis, Obesity
- Keywords
- Magnetic resonance imaging, Dynamic contrast enhanced MRI, Liraglutide 3 mg, Liraglutide, Obesity, Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Henrik GudbergsenUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 10 Oct 2016 (estimated)
- 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.
This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which patients will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.
This substudy aims to investigate the impact of, and subsequent change of, joint inflammation, articular cartilage composition, overall knee morphology, and clinical symptoms, in obese patients with knee osteoarthritis following a randomisation to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide 3 mg | Experimental | Drug: Liraglutide 3 mg (Saxenda)Arm description: Subjects will be up titrated to liraglutide 3 mg QD and stay on that dose for the remainder of the 52-week drug intervention period. Drug: Liraglutide 3 mg QD administered in a 6 mg/mL, 3 mL pen for subcutaneous injection. Dose escalation scheme: Initial dosage of 0.6 mg per day, escalated bi-weekly by 0.6 mg to 3 mg per day over a total of 8 weeks. |
| Liraglutide 3 mg placebo | Placebo comparator | Drug: Liraglutide 3 mg placeboArm description: Subjects will be up titrated to liraglutide 3 mg placebo QD and stay on that dose for the remainder of the 52-week drug intervention period. Drug: Liraglutide 3 mg placebo QD administered in a 6 mg/mL drug equivalent volumes, 3 mL pen for subcutaneous injection. Dose escalation scheme: Initial dosage of a 0.6 mg drug equivalent volume per day, escalated bi-weekly by an 0.6 mg drug equivalent volume per day to a 3 mg drug equivalent volume per day over a total of 8 weeks. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Same as parent trial (NCT02905864)
- Same as parent trial (NCT02905864)
- Usual exclusion criteria for MRI (i.e. pacemakers etc.)
Key exclusion criteria (0 listed)
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 3 mg (Saxenda) | Drug | Liraglutide 3 mg |
| Liraglutide 3 mg placebo | Drug | Liraglutide 3 mg placebo |
Primary outcome
Change in the degree of inflammation in the knee-joint (DCE-MRI)
Time frame: Week 0 to 52
Change will be assessed via a dynamic contrast enhanced MRI evaluation of corpus hoffa (Ballegaard C et al. and Riis RG et al.)
4 secondary outcomes
Change in the degree of inflammation in the knee-joint (CE-MRI)
Time frame: Week 0 to 52
Change in the degree of inflammation in the knee-joint (MRI)
Time frame: Week 0 to 52
Change in cartilage composition
Time frame: Week 0 to 52
Change in bone marrow lesions
Time frame: Week 0 to 52
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 25 Mar 2019.
- 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.
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 Phase 4 study testing Liraglutide 3 mg (Saxenda) in people with Osteoarthritis and Obesity, run by Henrik Gudbergsen 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 4 inclusion and 0 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 25 Mar 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in the degree of inflammation in the knee-joint (DCE-MRI) (time frame: Week 0 to 52). 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 25 Mar 2019.