NCT02928614

Brief Summary

This is a substudy to a randomized 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 they will be randomized 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 biomarkers in obese patients with knee osteoarthritis following a randomization to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

2.3 years

First QC Date

October 7, 2016

Last Update Submit

March 21, 2019

Conditions

OsteoarthritisObesity

Keywords

OsteoarthritisObesityLiraglutide 3 mgLiraglutideBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Change in collagen II degradation fragment α-C2M

    Blood sampling

    Week 0 to 52

Secondary Outcomes (5)

  • Change in collagen II degradation fragment β-C2M

    Week 0 to 52

  • Change in non-coding RNA type snoRNAs U38 and U48

    Week 0 to 52

  • Change in miRNA-454

    Week 0 to 52

  • Change in miRNA let-7e

    Week 0 to 52

  • Change in Nesfatin-1

    Week 0 to 52

Study Arms (2)

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.

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 placeboDRUG
Liraglutide 3 mg placebo

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Same as parent trial (NCT02905864)

You may not qualify if:

  • Same as parent trial (NCT02905864)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Parker Institute

Frederiksberg, Capital Region, 2000, Denmark

Location

MeSH Terms

Conditions

OsteoarthritisObesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, 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 10, 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)