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Completed
NCT05929079
A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
Conditions: Type 2 Diabetes, Obesity, Overweight, Obstructive Sleep Apnea
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1152
Sponsor: Eli Lilly and Company
Location: Pinnacle Research Group, LLC Anniston Alabama
Summary
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 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.
Source: ClinicalTrials.gov (NCT05929079). StuddyBuddy aggregates publicly available trial information.