For Healthcare Professionals

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

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

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

GSA2 Inclusion Criteria

  1. Previously diagnosed with OSA
  2. Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)
  3. 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.
  4. 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:

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

GSA2 Exclusion Criteria

  1. Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.
  2. Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.
  3. Use a dental appliance or other device to treat OSA other than PAP therapy.
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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.
Phone iconCall 1-317-615-4559Email iconEmail Study Center

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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