EUCTR2015-005163-16-DK
Active, not recruiting
Phase 1
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
The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark0 sites150 target enrollmentStarted: March 2, 2016Last updated:
ConditionsAdult (= 18 years of age) overweight or obese patients (BMI = 27 kg/m2 ) above 18 years of age with knee osteoarthritis (OA) defined by clinical diagnosis of knee OA according to the 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)MedDRA version: 19.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859MedDRA version: 19.0Level: LLTClassification code 10029885Term: Obesity, unspecifiedSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsSaxenda
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark
- Enrollment
- 150
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 75
Exclusion Criteria
- •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
- •Use of opioids or similar strong analgesics
- •Type 1 diabetes
- •Type 2 diabetes treated with glucose\-lowering drugs other than metformin
- •Alloplasty in target knee joint (see section 6\.3\)
- •End stage disease in target knee joint (Kellgren\-Lawrence grade 4\)
- •Pregnancy or insufficient anti\-conception therapy for female fertile patients
- •Breast\-feeding
Investigators
Similar Trials
Completed
Phase 4
Liraglutide 3 mg for Knee OsteoarthritisOsteoarthritisObesityNCT02905864Henrik Gudbergsen150
Active, not recruiting
Not Applicable
Efecto de liraglutida en el peso corporal en sujetos no diabéticos obesos o con sobrepeso y comorbilidad.Ensayo clínico aleatorizado, doble-ciego, controlado con placebo, grupos paralelos, multicéntrico, multinacional, con estratificación de sujetos a uno o tres años de tratamiento basada en el estatus pre-diabético en la aleatorizacióEUCTR2008-001049-24-ESovo Nordisk A/S4,800
Active, not recruiting
Not Applicable
Efecto de liraglutida en el peso corporal en sujetos con sobrepeso u obesos con diabetes tipo 2. Ensayo clínico de 1 año de duración, aleatorizado, doble-ciego, controlado con placebo, con tres grupos paralelos, multicéntrico, multinacional, con un periodo de seguimiento observacional de 12 semanas.Obesidad y sobrepesoMedDRA version: 9.1Level: LLTClassification code 10029883Term: ObesityMedDRA version: 9.1Level: LLTClassification code 10033307Term: OverweightEUCTR2008-002199-88-ESovo Nordisk A/S1,600
Active, not recruiting
Phase 1
Efecto de liraglutida sobre el peso corporal en sujetos obesos sin diabetesEnsayo de 20 semanas de duración, aleatorizado, doble ciego, controlado con placebo, en seis grupos paralelos, multicéntrico, multinacional con una rama abierta de comparación con orlistat con un período de extensión de 84 semanasObesidadObesityMedDRA version: 9.0Level: PTClassification code 10012601EUCTR2006-004481-13-ESovo Nordisk A/S
Active, not recruiting
Phase 1
Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes A 56 week randomised, double-blind, placebo-controlled, three armed parallel group, multi-centre, multinational trial with a 12 week observational follow-up period - SCALE™ - DiabetesObesity and overweightMedDRA version: 14.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.0 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2008-002199-88-GBovo Nordisk A/S