Changes in Skin Autoflouresence Following Weight Loss and Maintenance Using Liraglutide in Knee Osteoarthritis

NCT02910570 | Completed Phase 4 DMC

• 1 other identifier: 137.02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is sub-study to 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 (NCT02905864). In the parent trial 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. This sub-study of the parent trial only involves an additional assessment of skin auto fluorescence (AGE concentration) in the preallocation phase and in the main trial phase, i.e. from enrollment (defined as signature of informed consent) to treatment allocation (visits -Tx and T0 in the parent trial visit schedule) and from allocation to end of trial (visits T0 and T15 in the parent trial visit schedule).

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Change in advanced glycation end products in the skin

  advanced glycation end products levels will be measured on the skin of the volar side of the forearm using skin auto fluorescence

  week 0 to 52

Secondary Outcomes (1)

• Change in advanced glycation end products in the skin

  week -8 to 0 (pre-randomisation weight loss intervention)

Study Arms (2)

Liraglutide 3 mg

EXPERIMENTAL

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 (Saxenda)

Liraglutide 3 mg placebo

PLACEBO COMPARATOR

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

Interventions

Liraglutide 3 mg (Saxenda) DRUG

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

Liraglutide 3 mg placebo DRUG

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.

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

• Parker Research Institute: lead

Study Sites (1)

Department of Rheumatology

Frederiksberg, Capital Region, 2000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Henrik R Gudbergsen, MD, PhD

  The Parker Institute

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 22, 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)