## Protocol Section
### Identification Module
**NCT ID:** NCT02928679

**Acronym:** IM-LOSEIT-II

**Brief Title:** Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance

**Official Title:** Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis Following Liraglutide Treatment, Investigating the Impact on Inflammation

#### Organization Study ID Info
**ID:** 137.05
#### Organization
**Class:** OTHER
**Full Name:** Parker Research Institute
### Status Module
#### Completion Date
**Date:** 2019-03-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-03-25

**Type:** ACTUAL

**Last Update Submit Date:** 2019-03-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-02-20

**Type:** ACTUAL

#### Start Date
**Date:** 2016-11

**Status Verified Date:** 2019-03

#### Study First Post Date
**Date:** 2016-10-10
**Type:** ESTIMATED
**Study First Submit Date:** 2016-10-07
**Study First Submit QC Date:** 2016-10-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Henrik Gudbergsen

#### Responsible Party

**Investigator Affiliation:** Parker Research Institute

**Investigator Full Name:** Henrik Gudbergsen

**Investigator Title:** MD, PhD

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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 (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, articular cartilage composition, overall knee morphology, 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 Module

**Conditions:**

- Osteoarthritis

- Obesity

**Keywords:**

- Magnetic resonance imaging

- Dynamic contrast enhanced MRI

- Liraglutide 3 mg

- Liraglutide

- Obesity

- Osteoarthritis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: Liraglutide 3 mg (Saxenda)

**Label:** Liraglutide 3 mg

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Drug: Liraglutide 3 mg placebo

**Label:** Liraglutide 3 mg placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Liraglutide 3 mg

**Name:** Liraglutide 3 mg (Saxenda)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Liraglutide 3 mg placebo

**Name:** Liraglutide 3 mg placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Change will be assessed via a dynamic contrast enhanced MRI evaluation of corpus hoffa (Ballegaard C et al. and Riis RG et al.)

**Measure:** Change in the degree of inflammation in the knee-joint (DCE-MRI)

**Time Frame:** Week 0 to 52

#### Secondary Outcomes

**Description:** Change will be assessed via a static contrast enhanced MRI evaluation of the level of synovitis in the knee-joint (11 sites scored 0-2, ad modum Guermazi et al.)

**Measure:** Change in the degree of inflammation in the knee-joint (CE-MRI)

**Time Frame:** Week 0 to 52

**Description:** Change will be assessed via a conventional MRI evaluation of the level of synovitis and effusion (combined) in the knee-joint (MOAKS)

**Measure:** Change in the degree of inflammation in the knee-joint (MRI)

**Time Frame:** Week 0 to 52

**Description:** Change will be assessed via T2-maps of cartilage in the weight-bearing parts of the knee-joint (ROI)

**Measure:** Change in cartilage composition

**Time Frame:** Week 0 to 52

**Description:** Change will be assessed via the MRI knee scoring system MOAKS; BML sum-score

**Measure:** Change in bone marrow lesions

**Time Frame:** Week 0 to 52

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Same as parent trial (NCT02905864)

Further Exclusion Criteria:

* Same as parent trial (NCT02905864)
* Usual exclusion criteria for MRI (i.e. pacemakers etc.)

**Maximum Age:** 74 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Frederiksberg

**Country:** Denmark

**Facility:** The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital

**State:** Capital Region

**Zip:** 2000

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: HIGH

- As Found: Knee Osteoarthritis

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

- ID: D000020370

- Term: Osteoarthritis, Knee

### Intervention Browse Module - Ancestors

- ID: D000097789

- Term: Glucagon-Like Peptide-1 Receptor Agonists

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000054795

- Term: Incretins

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M419

- Name: Liraglutide

- Relevance: HIGH

- As Found: Ascending

- ID: M9043

- Name: Glucagon

- Relevance: LOW

- As Found: Unknown

- ID: M3401

- Name: Glucagon-Like Peptide-1 Receptor Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M26997

- Name: Glucagon-Like Peptide 1

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M27905

- Name: Incretins

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069450

- Term: Liraglutide

### Misc Info Module

- Version Holder: 2024-05-24
