Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance

NCT02931383 | Completed Phase 4 DMC

• 1 other identifier: 137.07
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 (OA) (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 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

Keywords

Liraglutide; Liraglutide 3 mg; Osteoarthritis; Obesity; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Change in the degree of inflammation in the knee-joint (Greyscale-score)

  Change will be assessed by grey-scale ultrasound (US) in the suprapatellar, the medial, and the lateral recess´ (sum-score (0-9), derived from these three positions)

  Week 0 to 52

Secondary Outcomes (3)

• Change in knee-joint effusion

  Week 0 to 52

• Change in the degree of inflammation in the knee-joint (Greyscale-size)

  Week 0 to 52

• Change in the degree of inflammation in the knee-joint (Doppler-score)

  Week 0 to 52

Study Arms (2)

Liraglutide 3 mg

EXPERIMENTAL

Arm description: Subjects will be up titrated to liraglutide 3 mg once daily (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.

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.

Drug: Liraglutide 3 mg placebo

Interventions

Liraglutide 3 mg (Saxenda) DRUG

Liraglutide 3 mg

Liraglutide 3 mg placebo DRUG

Liraglutide 3 mg placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Henrik Gudbergsen: lead

Study Sites (1)

The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital

Frederiksberg, Capital Region, 2000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis; Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 13, 2016
• Study Start: November 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

DK (1)