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A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight

CompletedPhase 3

Sponsor: Eli Lilly and Company

Conditions: Type 2 Diabetes, Obesity, Overweight, Obstructive Sleep Apnea

Interventions: Retatrutide, Placebo

Countries: United States, Argentina, Australia, Brazil, India, Mexico, Romania, Spain

The purpose of this study is to is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m ²)
* Have Type 2 Diabetes (T2D)
* Are on stable treatment for T2D for at least 90 days
* Have a history of at least one unsuccessful dietary effort to lose body weight.

GSA2 Inclusion Criteria

* Previously diagnosed with OSA
* Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)
* For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.
* If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.

Exclusion Criteria:

* Have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days.
* Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
* Have a prior or planned surgical treatment for obesity.
* Have Type 1 diabetes
* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* Have had pancreatitis

GSA2 Exclusion Criteria

* Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.
* Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.
* Use a dental appliance or other device to treat OSA other than PAP therapy.

Locations (98)

Anniston, Alabama, United States
Cullman, Alabama, United States
Little Rock, Arkansas, United States
Cerritos, California, United States
Los Angeles, California, United States
Northridge, California, United States
Walnut Creek, California, United States
Waterbury, Connecticut, United States
Boca Raton, Florida, United States
Brandon, Florida, United States
Fleming Island, Florida, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Ocala, Florida, United States
Pompano Beach, Florida, United States
West Palm Beach, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Rincon, Georgia, United States
Honolulu, Hawaii, United States
Indianapolis, Indiana, United States
Waltham, Massachusetts, United States
City of Saint Peters, Missouri, United States
Las Vegas, Nevada, United States
New Windsor, New York, United States
Monroe, North Carolina, United States
Morehead City, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
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