Clinical trial NCT05931367: A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee
Official title: A Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Overweight
Osteo Arthritis Knee
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-07-05
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the safety and efficacy of retatrutide once-weekly in participants who have obesity or are overweight and have osteoarthritis (OA) of the knee. The study will lasts about 77 weeks.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI) ≥27 kilogram/kg/m² at screening.
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
* Have index knee pain for \>12 weeks prior to screening, and presence of index knee pain for \>15 days over the previous month.
* Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening.
* Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.

Exclusion Criteria:

* Have had steroid joint injections within 90 days of screening.
* Have had other joint injections and procedures within 6 months of screening.
* Have joint disease other than osteoarthritis.
* Have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
* Have been taking weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
* Have a prior or planned surgical treatment for obesity.
* Have diabetes mellitus.

Primary outcomes:
measure: Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
timeFrame: Baseline, Week 68
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 68
Secondary outcomes:
measure: Change from Baseline in the WOMAC Physical Function Subscale Score
timeFrame: Baseline, Week 68
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 68
measure: Percent Change from Baseline in Total Cholesterol
timeFrame: Baseline, Week 68
measure: Percent Change from Baseline in Triglycerides
timeFrame: Baseline, Week 68
measure: Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 68
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 68
measure: Change from Baseline in Diastolic Blood Pressure (DBP)
timeFrame: Baseline, Week 68
measure: Percent Change from Baseline in Fasting Insulin
timeFrame: Baseline, Week 68
measure: Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
timeFrame: Baseline, Week 68
measure: Change from Baseline in Average Pain Intensity Numeric Rating Score (API-NRS) Score
timeFrame: Baseline, Week 68
measure: Change from Baseline in Worst Pain Intensity Numeric Rating Score (WPI-NRS) Score
timeFrame: Baseline, Week 68
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Dallas
country: United States
facility: Mercy Family Clinic
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Bruce
country: Australia
facility: Paratus Clinical Research Canberra
state: Australian Capital Territory
city: Blacktown
country: Australia
facility: Paratus Clinical Research Western Sydney
state: New South Wales
city: Botany
country: Australia
facility: Emeritus Research
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Core Research Group
state: Queensland
city: Maroochydore
country: Australia
facility: CDH Research Institute
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Calgary
country: Canada
facility: C-health Research
state: Alberta
city: St. John's
country: Canada
facility: Eastern Health - General Hospital
state: Newfoundland and Labrador
city: Bridgewater
country: Canada
facility: Viable Clinical Research
state: Nova Scotia
city: Hamilton
country: Canada
facility: Wharton Medical Clinic
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc.
state: Ontario
city: Scarborough
country: Canada
facility: Viable Clinical Research
state: Ontario
city: Stouffville
country: Canada
facility: Stouffville Medical Research Institute Inc.
state: Ontario
city: Toronto
country: Canada
facility: Canadian Phase Onward
state: Ontario
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Quebec
country: Canada
facility: ALPHA Recherche Clinique
city: Guadalajara
country: Mexico
facility: Consultorio Médico
state: Jalisco
city: Monterrey
country: Mexico
facility: IMED Internal Medicine Clin Trials
state: Nuevo León
city: Monterrey
country: Mexico
facility: Clínica García Flores SC
state: Nuevo León
city: San Nicolás de los Garza
country: Mexico
facility: Unidad Médica para la Salud Integral
state: Nuevo León
city: Ciudad Madero
country: Mexico
facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
state: Tamaulipas
city: Mérida
country: Mexico
facility: Kohler and Milstein Research S.A. de C.V.
state: Yucatán
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval")
state: A Coruña
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Málaga
country: Spain
facility: Hospital Quirón Málaga
state: Andalucía
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalunya
city: San Sebastián de Los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofía
state: Madrid
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
state: Valenciana
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña
city: Sevilla
country: Spain
facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
state: Leicestershire
city: Enfield
country: United Kingdom
facility: Panthera Biopartners - North London
state: London
city: Sheffield
country: United Kingdom
facility: Panthera Biopartners - Sheffield
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: