A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Type 2 Diabetes
Obesity
Overweight
Obstructive Sleep Apnea
Спонсор: Eli Lilly and Company
Налично на:
БГ
Обобщение
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.
Кой може да участва
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.
Места на провеждане
8
Argentina (1)
Consultorio de Investigación Clínica EMO SRL
Buenos Aires , Buenos Aires F.D.
Австралия (1)
Emeritus Research
Botany , New South Wales
Бразилия (1)
BR Trials - Ensaios Clinicos e Consultoria
São Paulo , São Paulo
Индия (1)
All India Institute of Medical Sciences
Raipur , Chhattisgarh
Mexico (1)
Centro de Investigacion en Artritis y Osteoporosis SC