A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05931367
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Canada, Mexico, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Obesity, Overweight, Osteo Arthritis Knee
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Retatrutide Dose 1

Participants will receive retatrutide subcutaneously (SC).

Experimental: Retatrutide Dose 2

Participants will receive retatrutide SC.

Placebo Comparator: Placebo

Participants will receive placebo.

Interventions

Drug: - Retatrutide

Administered SC

Drug: - Placebo

Administered SC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arizona Research Center, Phoenix, Arizona

Status

Recruiting

Address

Arizona Research Center

Phoenix, Arizona, 85053

Artemis Institute for Clinical Research, San Diego, California

Status

Recruiting

Address

Artemis Institute for Clinical Research

San Diego, California, 92103

Chase Medical Research, LLC, Waterbury, Connecticut

Status

Recruiting

Address

Chase Medical Research, LLC

Waterbury, Connecticut, 06708

Suncoast Research Group, Miami, Florida

Status

Recruiting

Address

Suncoast Research Group

Miami, Florida, 33135

North Georgia Clinical Research, Woodstock, Georgia

Status

Recruiting

Address

North Georgia Clinical Research

Woodstock, Georgia, 30189

Elite Clinical Trials, Blackfoot, Idaho

Status

Recruiting

Address

Elite Clinical Trials

Blackfoot, Idaho, 83221

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

MedVadis Research Corporation, Waltham, Massachusetts

Status

Recruiting

Address

MedVadis Research Corporation

Waltham, Massachusetts, 02451

Great Lakes Research Group, Inc., Bay City, Michigan

Status

Recruiting

Address

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706

Mercy Family Clinic, Dallas, Texas

Status

Recruiting

Address

Mercy Family Clinic

Dallas, Texas, 75211

Clinical Trials of Texas, Inc., San Antonio, Texas

Status

Recruiting

Address

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229

Northwest Clinical Research Center, Bellevue, Washington

Status

Recruiting

Address

Northwest Clinical Research Center

Bellevue, Washington, 98007

International Sites

Paratus Clinical Research Canberra, Bruce, Australian Capital Territory, Australia

Status

Recruiting

Address

Paratus Clinical Research Canberra

Bruce, Australian Capital Territory, 2617

Paratus Clinical Research Western Sydney, Blacktown, New South Wales, Australia

Status

Recruiting

Address

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, 2148

Optimus Clinical Research, Botany, New South Wales, Australia

Status

Recruiting

Address

Optimus Clinical Research

Botany, New South Wales, 2019

Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia

Status

Recruiting

Address

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029

Core Research Group, Brisbane, Queensland, Australia

Status

Recruiting

Address

Core Research Group

Brisbane, Queensland, 4064

Coastal Digestive Health, Maroochydore, Queensland, Australia

Status

Recruiting

Address

Coastal Digestive Health

Maroochydore, Queensland, 4558

Emeritus Research, Camberwell, Victoria, Australia

Status

Recruiting

Address

Emeritus Research

Camberwell, Victoria, 3124

Barwon Health, Geelong, Victoria, Australia

Status

Recruiting

Address

Barwon Health

Geelong, Victoria, 3220

C-health Research, Calgary, Alberta, Canada

Status

Recruiting

Address

C-health Research

Calgary, Alberta, T2V 4J2

Eastern Health - General Hospital, St. John's, Newfoundland and Labrador, Canada

Status

Recruiting

Address

Eastern Health - General Hospital

St. John's, Newfoundland and Labrador, A1B 3V6

Viable Clinical Research, Bridgewater, Nova Scotia, Canada

Status

Recruiting

Address

Viable Clinical Research

Bridgewater, Nova Scotia, B4V 3N2

Wharton Medical Clinic, Hamilton, Ontario, Canada

Status

Recruiting

Address

Wharton Medical Clinic

Hamilton, Ontario, L8L 5G8

Bluewater Clinical Research Group Inc., Sarnia, Ontario, Canada

Status

Recruiting

Address

Bluewater Clinical Research Group Inc.

Sarnia, Ontario, N7T 4X3

Viable Clinical Research, Scarborough, Ontario, Canada

Status

Recruiting

Address

Viable Clinical Research

Scarborough, Ontario, M1P 2T7

Stouffville Medical Centre, Stouffville, Ontario, Canada

Status

Completed

Address

Stouffville Medical Centre

Stouffville, Ontario, L4A 1H2

Canadian Phase Onward, Toronto, Ontario, Canada

Status

Recruiting

Address

Canadian Phase Onward

Toronto, Ontario, M3J 0K2

Alpha Recherche Clinique, Quebec, Canada

Status

Recruiting

Address

Alpha Recherche Clinique

Quebec, , G2J 0C4

Consultorio Médico, Guadalajara, Jalisco, Mexico

Status

Recruiting

Address

Consultorio Médico

Guadalajara, Jalisco, 44210

IMED Internal Medicine Clin Trials, Monterrey, Nuevo León, Mexico

Status

Recruiting

Address

IMED Internal Medicine Clin Trials

Monterrey, Nuevo León, 64060

Clínica García Flores SC, Monterrey, Nuevo León, Mexico

Status

Recruiting

Address

Clínica García Flores SC

Monterrey, Nuevo León, 64610

Unidad Médica para la Salud Integral, San Nicolás de los Garza, Nuevo León, Mexico

Status

Recruiting

Address

Unidad Médica para la Salud Integral

San Nicolás de los Garza, Nuevo León, 66465

Ciudad Madero, Tamaulipas, Mexico

Status

Recruiting

Address

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

Ciudad Madero, Tamaulipas, 89440

Mérida, Yucatán, Mexico

Status

Recruiting

Address

Kohler and Milstein Research S.A. de C.V.

Mérida, Yucatán, 97070

Investigacion y Biomedicina de Chihuahua, Chihuahua, Mexico

Status

Recruiting

Address

Investigacion y Biomedicina de Chihuahua

Chihuahua, , 31000

A Coruña, A Coruña [La Coruña], Spain

Status

Recruiting

Address

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña [La Coruña], 15006

Ferrol, A Coruña [La Coruña], Spain

Status

Recruiting

Address

Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval")

Ferrol, A Coruña [La Coruña], 15405

Hospital Universitario Reina Sofia, Cordoba, Andalucía, Spain

Status

Recruiting

Address

Hospital Universitario Reina Sofia

Cordoba, Andalucía, 14004

Hospital de la Santa Creu i Sant Pau, Barcelona, Catalunya [Cataluña], Spain

Status

Recruiting

Address

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña], 08041

Hospital Universitario Infanta Sofía, San Sebastián de Los Reyes, Madrid, Comunidad De, Spain

Status

Recruiting

Address

Hospital Universitario Infanta Sofía

San Sebastián de Los Reyes, Madrid, Comunidad De, 28702

Valencia, Valenciana, Comunitat, Spain

Status

Recruiting

Address

Hospital General Universitario de Valencia

Valencia, Valenciana, Comunitat, 46014

Hospital Quirón Málaga, Málaga, Spain

Status

Recruiting

Address

Hospital Quirón Málaga

Málaga, , 29004

Sevilla, Spain

Status

Recruiting

Address

Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

Sevilla, , 41003

Leicester General Hospital, Leicester, Leicestershire, United Kingdom

Status

Recruiting

Address

Leicester General Hospital

Leicester, Leicestershire, LE5 4PW

Panthera Biopartners - North London, Enfield, London, City Of, United Kingdom

Status

Recruiting

Address

Panthera Biopartners - North London

Enfield, London, City Of, EN3 4GS

Panthera Biopartners - Sheffield, Sheffield, United Kingdom

Status

Recruiting

Address

Panthera Biopartners - Sheffield

Sheffield, , S2 5FX