OsteoarthritisPhase 4LOSEITNCT02905864
Liraglutide 3 mg for Knee Osteoarthritis
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
A randomised, double blind, placebo-controlled, parallel group, and single-centre trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis. 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 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
- Informed consent obtained
- Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) confirmed by radiology but restricted to definite radiographic OA at early to moderate-stages (Kellgren-Lawrence grades 1, 2, or 3)
- Age ≥ 18 years and < 75 years
- Body mass index (BMI) ≥ 27 kg/m2
- Stable body weight during the previous 3 months (< 5 kg self-reported weight change)
- Motivated for weight loss
Who cannot join
- On-going participation, or participation within the last 3 months, in an organised weight loss programme (or within the last 3 months)
- Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
- Current use or use within three months before this trial of GLP-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate, or phentermine
- Type 1 diabetes
- Type 2 diabetes treated with glucose-lowering drugs other than metformin
- Alloplasty in target knee joint (see section 6.3)
Show all 30Show fewer
- End stage disease in target knee joint (Kellgren-Lawrence grade 4)
- Immuno-inflammatory disease
- Chronic wide-spread pain
- Pregnancy or insufficient anti-conception therapy for female fertile patients
- Breast-feeding
- Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x above upper normal range (UNR)
- Surgery scheduled for the trial duration period, except for minor surgical procedures
- Surgical procedures such as arthroscopy or injections into a knee within 3 months prior to enrolment
- Previous surgical treatment for obesity (excluding liposuction >1 year before trial entry)
- Thyroid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L
- Obesity secondary to endocrinologic or eating disorders or to treatment with medicinal products that may cause weight gain
- Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Inflammatory bowel disease
- Congestive heart failure, New York Heart Association (NYHA) class III-IV
- Diabetic gastroparesis
- History of or current diagnosis of pancreatitis (acute and/or chronic) or pancreatic cancer
- History of cancer with the exception of in-situ malignancies of the skin or cervix uteri
- History of major depressive disorder, a PHQ-9 (Patient Health Questionnaire-9) score of more than 15, or a history of other severe psychiatric disorders or diagnosis of an eating disorder
- Subjects with a lifetime history of a suicide attempt or history of any suicidal behaviour within the past month before entry into the trial
- Inability to speak Danish fluently
- A mental state impeding compliance with the program
- Use of opioids or similar strong analgesics
- Allergic reactions to the active ingredients of Saxenda, such as hypotension, palpitations, dyspnoea and oedema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Liraglutide on Body Weight and Pain in Overweight or Obese Patients With Knee Osteoarthritis: A Randomised, Double Blind, Placebo-controlled, Parallel Group, Single-centre Trial
A randomised, double blind, placebo-controlled, parallel group, and single-centre trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis.
Patients will be subjected to a run-in diet intervention phase (week -8 to 0) including a low-calorie diet and dietetic counselling. At week 0 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.
- Conditions
- Osteoarthritis, Obesity
- Being tested
- Liraglutide 3 mg (Saxenda), Liraglutide 3 mg placebo
- Keywords
- Liraglutide, Liraglutide 3 mg, Osteoarthritis, Obesity
- 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 body weight
One of two co-primary outcomes
Measured: Week 0 to 52
KOOS pain subscale
Two of two co-primary outcomes. The Knee injury and Osteoarthritis Outcome Score (KOOS); the pain subscale (9 items)
Measured: Week 0 to 52
Secondary outcomes (15)
KOOS symptom subscale
Knee injury and Osteoarthritis Outcome Score (KOOS); the symptoms subscale (7 items)
Measured: Week 0 to 52
KOOS ADL subscale
Knee injury and Osteoarthritis Outcome Score (KOOS); the Activities of Daily Living (ADL) subscale (17 items)
Measured: Week 0 to 52
KOOS sport and recreation subscale
Knee injury and Osteoarthritis Outcome Score (KOOS); the sport and recreation subscale (5 items)
Measured: Week 0 to 52
KOOS health related QoL subscale
Knee injury and Osteoarthritis Outcome Score (KOOS); the health related quality of life (QoL) subscale (4 items)
Measured: Week 0 to 52
Change in total score in the ICOAP questionnaire
The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 11 items
Measured: Week 0 to 52
Change in the constant pain subscale in the ICOAP questionnaire
The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 5 items
Measured: Week 0 to 52
Change in the intermittent pain subscale in the ICOAP questionnaire
The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 6 items
Measured: Week 0 to 52
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale; 5 items
Measured: Week 0 to 52
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness subscale
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness subscale; 2 items
Measured: Week 0 to 52
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale; 17 items
Measured: Week 0 to 52
Proportion of participants with ≥5% weight loss
The proportion of patients with or with more than a 5% weight loss 52 weeks after randomization
Measured: Week 0 to 52
Proportion of participants with ≥10% weight loss
The proportion of patients with or with more than a 10% weight loss 52 weeks after randomization
Measured: Week 0 to 52
Change in BMI
Change in body mass index 52 weeks after randomization
Measured: Week 0 to 52
Change in waist circumference
Change in waist circumference 52 weeks after randomization
Measured: Week 0 to 52
Change in waist/hip circumference ratio
Change in the ratio waist circumference/hip circumference 52 weeks after randomization
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 posted19 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionFeb 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Collaborators
- Novo Nordisk A/S, Cambridge Weight Plan Limited
- Responsible party
- Sponsor-investigator, Henrik Gudbergsen, Parker Research Institute
- Investigators
- Henrik R Gudbergsen, MD, PhD, Principal investigator, The Parker Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905864
- Sponsor's protocol ID
- 137.00
- Acronym
- LOSEIT
- Status last verified
- Mar 2019
- First submitted
- 14 Sep 2016
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Poulsen AS, Stisen ZR, Skougaard M, Christensen R, Overgaard A, Gudbergsen H, Jacobsen S, Balslev-Clausen AP, Henriksen M, Kristensen LE, Bliddal H. Effect of weight loss and liraglutide on neutrophil gelatinase-associated lipocalin levels among individuals with overweight and knee osteoarthritis: Exploratory analyses of a randomized controlled trial. Osteoarthr Cartil Open. 2025 Jan 3;7(1):100562. doi: 10.1016/j.ocarto.2024.100562. eCollection 2025 Mar.
PubMed 39877802Gudbergsen H, Overgaard A, Henriksen M, Waehrens EE, Bliddal H, Christensen R, Nielsen SM, Boesen M, Knop FK, Astrup A, Rasmussen MU, Bartholdy C, Daugaard CL, Ellegaard K, Heitmann BL, Bartels EM, Danneskiold-Samsoe B, Kristensen LE. Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial. Am J Clin Nutr. 2021 Feb 2;113(2):314-323. doi: 10.1093/ajcn/nqaa328.
PubMed 33471039Daugaard CL, Henriksen M, Riis RGC, Bandak E, Nybing JD, Hangaard S, Bliddal H, Boesen M. The impact of a significant weight loss on inflammation assessed on DCE-MRI and static MRI in knee osteoarthritis: a prospective cohort study. Osteoarthritis Cartilage. 2020 Jun;28(6):766-773. doi: 10.1016/j.joca.2020.02.837. Epub 2020 Mar 10.
PubMed 32165240Gudbergsen H, Henriksen M, Waehrens EE, Overgaard A, Bliddal H, Christensen R, Boesen MP, Knop FKK, Astrup A, Rasmussen MU, Bartholdy C, Daugaard C, Bartels EM, Ellegaard K, Heitmann BL, Kristensen LE. Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial. BMJ Open. 2019 May 5;9(5):e024065. doi: 10.1136/bmjopen-2018-024065.
PubMed 31061017
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
- Effect of Liraglutide on Body Weight and Pain in Overweight or Obese Patients With Knee Osteoarthritis: A Randomised, Double Blind, Placebo-controlled, Parallel Group, Single-centre Trial
- ClinicalTrials.gov ID
- NCT02905864
- Acronym / sponsor ID
- LOSEIT / 137.00
- Conditions
- Osteoarthritis, Obesity
- Keywords
- Liraglutide, Liraglutide 3 mg, Osteoarthritis, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Henrik GudbergsenUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Cambridge Weight Plan Limited
- Study start
- Nov 2016
- Primary completion
- Feb 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 19 Sep 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.
A randomised, double blind, placebo-controlled, parallel group, and single-centre trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis.
Patients will be subjected to a run-in diet intervention phase (week -8 to 0) including a low-calorie diet and dietetic counselling. At week 0 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.
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 (6 listed)
- Informed consent obtained
- Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) confirmed by radiology but restricted to definite radiographic OA at early to moderate-stages (Kellgren-Lawrence grades 1, 2, or 3)
- Age ≥ 18 years and < 75 years
- Body mass index (BMI) ≥ 27 kg/m2
- Stable body weight during the previous 3 months (< 5 kg self-reported weight change)
Key exclusion criteria (30 listed)
- On-going participation, or participation within the last 3 months, in an organised weight loss programme (or within the last 3 months)
- Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
- Current use or use within three months before this trial of GLP-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate, or phentermine
- Type 1 diabetes
- Type 2 diabetes treated with glucose-lowering drugs other than metformin
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 body weight
Time frame: Week 0 to 52
One of two co-primary outcomes
KOOS pain subscale
Time frame: Week 0 to 52
Two of two co-primary outcomes. The Knee injury and Osteoarthritis Outcome Score (KOOS); the pain subscale (9 items)
15 secondary outcomes
KOOS symptom subscale
Time frame: Week 0 to 52
KOOS ADL subscale
Time frame: Week 0 to 52
KOOS sport and recreation subscale
Time frame: Week 0 to 52
KOOS health related QoL subscale
Time frame: Week 0 to 52
Change in total score in the ICOAP questionnaire
Time frame: Week 0 to 52
Change in the constant pain subscale in the ICOAP questionnaire
Time frame: Week 0 to 52
Change in the intermittent pain subscale in the ICOAP questionnaire
Time frame: Week 0 to 52
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale
Time frame: Week 0 to 52
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness subscale
Time frame: Week 0 to 52
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale
Time frame: Week 0 to 52
Proportion of participants with ≥5% weight loss
Time frame: Week 0 to 52
Proportion of participants with ≥10% weight loss
Time frame: Week 0 to 52
Change in BMI
Time frame: Week 0 to 52
Change in waist circumference
Time frame: Week 0 to 52
Change in waist/hip circumference ratio
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.
- Derived from this study: PubMed 39877802Poulsen AS, Stisen ZR, Skougaard M, Christensen R, Overgaard A, Gudbergsen H, Jacobsen S, Balslev-Clausen AP, Henriksen M, Kristensen LE, Bliddal H. Effect of weight loss and liraglutide on neutrophil gelatinase-associated lipocalin levels among individuals with overweight and knee osteoarthritis: Exploratory analyses of a randomized controlled trial. Osteoarthr Cartil Open. 2025 Jan 3;7(1):100562. doi: 10.1016/j.ocarto.2024.100562. eCollection 2025 Mar.
- Derived from this study: PubMed 33471039Gudbergsen H, Overgaard A, Henriksen M, Waehrens EE, Bliddal H, Christensen R, Nielsen SM, Boesen M, Knop FK, Astrup A, Rasmussen MU, Bartholdy C, Daugaard CL, Ellegaard K, Heitmann BL, Bartels EM, Danneskiold-Samsoe B, Kristensen LE. Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial. Am J Clin Nutr. 2021 Feb 2;113(2):314-323. doi: 10.1093/ajcn/nqaa328.
- Derived from this study: PubMed 32165240Daugaard CL, Henriksen M, Riis RGC, Bandak E, Nybing JD, Hangaard S, Bliddal H, Boesen M. The impact of a significant weight loss on inflammation assessed on DCE-MRI and static MRI in knee osteoarthritis: a prospective cohort study. Osteoarthritis Cartilage. 2020 Jun;28(6):766-773. doi: 10.1016/j.joca.2020.02.837. Epub 2020 Mar 10.
- Derived from this study: PubMed 31061017Gudbergsen H, Henriksen M, Waehrens EE, Overgaard A, Bliddal H, Christensen R, Boesen MP, Knop FKK, Astrup A, Rasmussen MU, Bartholdy C, Daugaard C, Bartels EM, Ellegaard K, Heitmann BL, Kristensen LE. Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial. BMJ Open. 2019 May 5;9(5):e024065. doi: 10.1136/bmjopen-2018-024065.
- 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.
Henrik R Gudbergsen, MD, PhD principal investigator
The Parker Institute
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 6 inclusion and 30 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 body weight (time frame: Week 0 to 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02905864, which also lists 4 linked publications.
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.