A Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight
A Phase 2b, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight and Without Type 2 Diabetes
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Physicians interested in becoming principal investigators please contact
- Email: clinical_inquiry_hub@lilly.com
Study Contact Backup
- Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Phone Number: 317-615-4559
- Email: LillyTrials@Lilly.com
Study Locations
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Arizona
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Chandler, Arizona, United States, 85225
- Recruiting
- The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
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Principal Investigator:
- Yessica Sachdeva
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Scottsdale, Arizona, United States, 85260
- Recruiting
- Headlands Research - Scottsdale
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Principal Investigator:
- Benjamin Clark
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Tucson, Arizona, United States, 85712
- Recruiting
- The Institute for Liver Health II dba Arizona Liver Health-Tucson
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Principal Investigator:
- Anita Kohli
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California
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Greenbrae, California, United States, 94904
- Recruiting
- NorCal Medical Research, Inc
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Principal Investigator:
- Linda Gaudiani
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Huntington Park, California, United States, 90255
- Recruiting
- Velocity Clinical Research, Huntington Park
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Principal Investigator:
- Stanley Hsia
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Rolling Hills Estates, California, United States, 90274
- Recruiting
- Peninsula Research Associates
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Principal Investigator:
- LeighAnn Schmidt
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Walnut Creek, California, United States, 94598
- Recruiting
- Diablo Clinical Research, Inc.
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Principal Investigator:
- Mark Christiansen
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Connecticut
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Stamford, Connecticut, United States, 06905
- Recruiting
- Stamford Therapeutics Consortium
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Principal Investigator:
- David Radin
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Florida
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Miami, Florida, United States, 33165
- Recruiting
- New Horizon Research Center
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Principal Investigator:
- Lazaro Nunez
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Miami Lakes, Florida, United States, 33016
- Recruiting
- Indago Research & Health Center, Inc
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Principal Investigator:
- Jose Cardona
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New Port Richey, Florida, United States, 34652
- Recruiting
- Suncoast Clinical Research, Inc.
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Principal Investigator:
- Cathy Barnes
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Orlando, Florida, United States, 32803
- Recruiting
- Charter Research - Winter Park
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Principal Investigator:
- Edgardo Rivera-Rivera
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The Villages, Florida, United States, 32162
- Recruiting
- Charter Research - Lady Lake
-
Principal Investigator:
- Jeffrey Norton
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Idaho
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Ammon, Idaho, United States, 83406
- Recruiting
- Medical Research Partners
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Principal Investigator:
- Joseph Moore
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Illinois
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Chicago, Illinois, United States, 60640
- Recruiting
- Great Lakes Clinical Trials - Ravenswood
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Principal Investigator:
- Rupal Trivedi
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Kansas
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Topeka, Kansas, United States, 66606
- Recruiting
- Cotton O'Neil Diabetes & Endocrinology
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Principal Investigator:
- susan brian
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Kentucky
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Louisville, Kentucky, United States, 40213
- Recruiting
- Monroe Biomedical Research - Louisville
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Principal Investigator:
- Harold Bays
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Massachusetts
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Needham, Massachusetts, United States, 02492
- Recruiting
- Knownwell
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Principal Investigator:
- Angela Fitch
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New Bedford, Massachusetts, United States, 02740
- Recruiting
- Lucida Clinical Trials
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Principal Investigator:
- David Shih
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Michigan
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Southfield, Michigan, United States, 48034
- Recruiting
- Headlands Research - Detroit
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Principal Investigator:
- Christopher Romero
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Troy, Michigan, United States, 48098
- Recruiting
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
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Principal Investigator:
- Neil Fraser
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Missouri
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City of Saint Peters, Missouri, United States, 63303
- Recruiting
- StudyMetrix Research
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Principal Investigator:
- Timothy Smith
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Springfield, Missouri, United States, 65807
- Recruiting
- Clinvest Headlands Llc
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Principal Investigator:
- Christina Capps
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Nevada
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Las Vegas, Nevada, United States, 89128
- Recruiting
- Las Vegas Medical Research
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Principal Investigator:
- Cornell Calinescu
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New York
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Amherst, New York, United States, 14226
- Recruiting
- Dent Neurologic Institute
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Principal Investigator:
- Laszlo Mechtler
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Rochester, New York, United States, 14609
- Recruiting
- Rochester Clinical Research, LLC
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Principal Investigator:
- Patrick Connors
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North Carolina
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Greensboro, North Carolina, United States, 27405
- Recruiting
- Medication Management
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Principal Investigator:
- James Franklin
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Monroe, North Carolina, United States, 28112
- Recruiting
- Monroe Biomedical Research
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Principal Investigator:
- Awawu Igbinadolor
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Morehead City, North Carolina, United States, 28557
- Recruiting
- Lucas Research, Inc
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Principal Investigator:
- Kathryn Lucas
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New Bern, North Carolina, United States, 28562
- Recruiting
- Lucas Research, Inc.
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Principal Investigator:
- Joseph Maides
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Ohio
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Cincinnati, Ohio, United States, 45212
- Recruiting
- CTI Clinical Research Center
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Principal Investigator:
- James Maynard
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South Carolina
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Greenville, South Carolina, United States, 29607
- Recruiting
- Tribe Clinical Research, LLC
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Principal Investigator:
- Ronald Mayfield
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Tennessee
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Nashville, Tennessee, United States, 37211
- Recruiting
- Quality Medical Research
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Principal Investigator:
- Saras Sharma
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Texas
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Austin, Texas, United States, 78745
- Recruiting
- IMA Clinical Research Austin
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Principal Investigator:
- Nomita Kim
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Dallas, Texas, United States, 75251
- Recruiting
- FutureSearch Trials of Dallas
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Principal Investigator:
- Michael Downing
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Houston, Texas, United States, 77079
- Recruiting
- PlanIt Research, PLLC
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Principal Investigator:
- Amer Al-Karadsheh
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San Antonio, Texas, United States, 78240
- Recruiting
- Endeavor Clinical Trials
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Principal Investigator:
- Nitendra Agarwal
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Weslaco, Texas, United States, 78596
- Recruiting
- Texas Valley Clinical Research
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Principal Investigator:
- Eduardo Luna
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Virginia
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Danville, Virginia, United States, 24541
- Recruiting
- Sovah Clinical Research-River District
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Principal Investigator:
- Stephan Jannach
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Washington
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Wenatchee, Washington, United States, 98801
- Recruiting
- Central Washington Health Services Association d/b/a Confluence Health
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Principal Investigator:
- Kathryn Eren
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- See Master Protocol CWMM (NCT06143956) for inclusion criteria
Exclusion Criteria:
In addition to exclusion criteria in Master Protocol CWMM (NCT06143956):
- Have type 1 diabetes or type 2 diabetes
- Have an ongoing history of bradyarrhythmia and/or sinus bradycardia
- Have an elevated resting pulse rate (greater than 100 bpm) or reduced resting pulse rate (less than 60 bpm)
- Have a history of acute or chronic pancreatitis
- All concomitant medications should be at a stable dose for at least 3 months prior to screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Participants will receive placebo SC
|
Administered SC
|
|
Experimental: Eloralintide Dose 2
Participants will receive eloralintide SC
|
Administered SC
Other Names:
|
|
Experimental: Eloralintide Dose 3
Participants will receive eloralintide SC
|
Administered SC
Other Names:
|
|
Experimental: Macupatide Dose 1
Participants will receive macupatide subcutaneously (SC)
|
Administered SC
Other Names:
|
|
Experimental: Eloralintide Dose 1
Participants will receive eloralintide SC
|
Administered SC
Other Names:
|
|
Experimental: Macupatide Dose 1 + Eloralintide Dose 1
Participants will receive macupatide SC and eloralintide SC
|
Administered SC
Other Names:
Administered SC
Other Names:
|
|
Experimental: Macupatide Dose 1 + Eloralintide Dose 2
Participants will receive macupatide SC and eloralintide SC
|
Administered SC
Other Names:
Administered SC
Other Names:
|
|
Experimental: Macupatide Dose 2 + Eloralintide Dose 3
Participants will receive macupatide SC and eloralintide SC
|
Administered SC
Other Names:
Administered SC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 36
|
Baseline, Week 36
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 36
|
Baseline, Week 36
|
|
Change from Baseline in Body Weight
Time Frame: Baseline, Week 36
|
Baseline, Week 36
|
|
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Time Frame: Week 36
|
Week 36
|
|
Percentage of Participants who Achieve ≥10% Body Weight Reduction
Time Frame: Week 36
|
Week 36
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 27844
- W8M-MC-CWMM (Other Identifier: Eli Lilly and Company)
- W8M-MC-MC01 (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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