Table 1.

Key eligibility criteria.

Key inclusion criteria
• Adult males or females aged ≥18 years  • Body mass index ≥30 kg/m2	• Apnea-hypopnea index ≥15 events/hour  • History of ≥1 self-reported unsuccessful dietary effort to lose body weight
Key exclusion criteria
Diabetes related
• HbA1c ≥6.5% at V1, and history of type 1 or 2 diabetes mellitus, ketoacidosis, or hyperosmolar state/coma
OSA related
• Any previous or planned surgery for sleep apnea or major ear, nose, or throat surgery  • Significant craniofacial abnormalities that may affect breathing  • Diagnosis of central or mixed sleep apnea, or diagnosis of Cheyne-Stokes respiration	• Active device treatment of OSA other than positive airway pressure therapy  • Respiratory and neuromuscular diseases that could interfere with the trial results
Obesity related
• Have a self-reported change in body weight >5 kg within 3 months prior to screening	• Have a prior or planned surgical or endoscopic treatment for obesity
Medical
• History of disorder, other than OSA, associated with insomnia or excessive daytime sleepiness  • Impaired renal function, defined as eGFR <30 mL/min/1.73 m2  • Known clinically significant gastric emptying abnormality or use of drugs affecting gastrointestinal motility  • History of chronic or acute pancreatitis  • Thyroid-stimulating hormone outside the range of 0.4–6.0 mIU/L  • Obesity induced by other endocrinologic disorders, or monogenetic or syndromic forms of obesity  • Deemed to be at significant risk for suicide per C-SSRS or investigator’s judgment  • Patient Health Questionnaire-9 score of ≥15 at V1 or V2, prior to randomization  • Uncontrolled hypertension (SBP ≥160 mmHg and/or DBP ≥100 mmHg)  • Acute MI, cerebrovascular accident (stroke), unstable angina, or hospitalization due to CHF within 3 months prior to randomization  • History of (<3 months prior to V1) or planned cardiovascular procedure  • NYHA functional class IV CHF  • Calcitonin level ≥20 ng/L at screening, if eGFR ≥60 mL/min/1.73 m2, or ≥35 ng/L, if eGFR <60 mL/min/1.73 m2  • Acute or chronic hepatitis or other liver disease (excluding nonalcoholic fatty liver disease)  • ALT >3 × ULN for the reference range or ALP >1.5 × ULN or total bilirubin >1.2 × ULN (except for Gilbert syndrome)	• History of or in remission from malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for <5 years  • Family or personal history of MTC or MEN2  • History of marijuana use within <3 months of V1 and unwillingness to abstain from it during the trial  • Have had a transplanted organ (corneal transplants [keratoplasty] allowed) or awaiting an organ transplant  • Requires the use of supplemental oxygen  • Concomitant therapy (current or within 3 months prior to screening)  • Use of a GLP-1 RA <3 months prior to V1  • Use of metformin or any other glucose-lowering medication (whether prescribed for PCOS or diabetes prevention)  • Use of systemic glucocorticoid therapy  • Use of medications that may cause weight gain such as tricyclic antidepressants, atypical antipsychotics, and mood stabilizers  • Use of medication or alternative therapies that promote weight loss  • Use of stimulants <3 months prior to V1  • Use of hypnotics, mirtazapine, opioids, or trazodone <3 months prior to V1  • Use of any over-the-counter or prescription medications that could affect the evaluation of excessive sleepiness

Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; DBF, diastolic blood pressures; CHF, congestive heart failure; C-SSRS, Columbia-Suicide Severity Rating Scale; eGFR, estimated glomerular filtration rate; GLP-1 RA, glucagon-like peptide 1 receptor agonist; MEN2 multiple endocrine neoplasia type 2; MI, myocardial infarction; MTC, medullary thyroid cancer; NYHA, New York Heart Association; OSA, obstructive sleep apnea; PCOS, polycystic ovary syndrome; SBP, systolic blood pressure; ULN, upper limit of normal; V1, Visit 1; V2, Visit 2.