What this trial means for you
This study is active, not recruiting. It is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Retatrutide, Placebo for type 2 diabetes, obesity, overweight.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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.
Study sites by state
Alabama
- Pinnacle Research Group, LLC, Anniston
- Cullman Clinical Trials, Cullman
Arkansas
- Preferred Research Partners, Little Rock
California
- Core Healthcare Group, Cerritos
- Velocity Clinical Research, Westlake, Los Angeles
- Valley Clinical Trials, Inc., Northridge
- Diablo Clinical Research, Inc., Walnut Creek
Connecticut
- Chase Medical Research, LLC, Waterbury
Florida
- Excel Medical Clinical Trials, Boca Raton
- Teradan Clinical Trials, LLC, Brandon
- Fleming Island Center for Clinical Research, Fleming Island
- Therafirst Medical Center, Fort Lauderdale
- Clinical Site Partners LLC, dba Flourish Research, Miami
- Quantum Clinical Trials, Miami Beach
- Renstar Medical Research, Ocala
- Clinical Research Center of Florida, Pompano Beach
- Palm Beach Research Center, West Palm Beach
- Clinical Site Partners, LLC dba Flourish Research, Winter Park
Georgia
- NeuroTrials Research Inc, Atlanta
- Centricity Research Rincon Pulmonology, Rincon
Hawaii
- East-West Medical Research Institute, Honolulu
Indiana
- Brengle Family Medicine, Indianapolis
Massachusetts
- MedVadis Research Corporation, Waltham
Missouri
- StudyMetrix Research, City of Saint Peters
Nevada
- Las Vegas Medical Research, Las Vegas
New York
- Mid Hudson Medical Research, New Windsor
North Carolina
- Monroe Biomedical Research, Monroe
- Carteret Medical Group, Morehead City
North Dakota
- Lillestol Research, Fargo
Ohio
- CTI Clinical Research Center, Cincinnati
- Intrepid Research, Cincinnati
Pennsylvania
- Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18), Pittsburgh
- Preferred Primary Care Physicians, Uniontown
South Carolina
- Tribe Clinical Research, LLC, Greenville
- Trial Management Associates, Myrtle Beach
- Tribe Clinical Research - Spartanburg, Spartanburg
Texas
- FutureSearch Trials of Neurology, Austin
- Velocity Clinical Research, Dallas, Dallas
Utah
- Advanced Research Institute, Ogden
Washington
- Northwest Clinical Research Center, Bellevue
View the official record on ClinicalTrials.gov →
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