A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Type 2 Diabetes,Obesity,Overweight,Obstructive Sleep Apnea
Age
18+
Phase
PHASE3
Participants Needed
1000
Est. Completion Date
May 31, 2026
Treatment Type
INTERVENTIONAL
Sponsor
Eli Lilly and Company
ClinicalTrials.gov NCT Identifier
NCT05929079
Study Number
J1I-MC-GSA2
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