Phase
Condition
N/ATreatment
N/AClinical Study ID
Study Summary
Eligibility Criteria
Inclusion
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.
Exclusion
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.