Previous and/or concomitant therapy
obesity, ketoacidosis, monogenetic or syndromic forms, anxiety, malignancy, diabetes mellitus, psychiatric, myocardial infarctioncerebrovascular, autoimmune abnormality, ideation, anxiety disorder, bipolar disorder, weight gain, lupus, initiation of thyroid hormone replacement, schizophrenia, hypothyroidism, diabetes, gastric outlet obstruction) or chronically, suicide-related behaviors, medullary thyroid carcinoma, gastroparesis, polycystic ovarian syndrome, MDD, ideation or behavior, hypersensitivity, endocrinologic disorders, NAFLD, liver disease, alcohol abuse, eating disorder
OBESITY, RHEUMATOID ARTHRITIS, KETOACIDOSIS, SICKLE CELL DISEASE, SQUAMOUS CELL SKIN CANCER, NONALCOHOLIC FATTY LIVER DISEASE, DIABETES MELLITUS, HEART, IN SITU CARCINOMA, REMISSION, LUPUS, MULTIPLE ENDOCRINE NEOPLASIA SYNDROME TYPE 1, HYPOTHYROIDISM, SUBCLINICAL HYPOTHYROIDISM, DIABETES, MEDULLARY THYROID CARCINOMA, GASTROPARESIS, POLYCYSTIC OVARIAN SYNDROME, CHRONIC HEPATITIS, TYPE 2 DIABETES MELLITUS, GILBERT, PROSTATE CANCER, HYPERSENSITIVITY, DISORDER, UNCONTROLLED HYPERTENSION, DISEASE, LIVER DISEASE, CUSHING SYNDROME, HEMOLYTIC ANEMIAS

had type 1 or type 2 diabetes mellitus, history of ketoacidosis or hyperosmolar state/comahad at least one laboratory value suggestive of diabetes mellitus during screening, including one or more of: HbA1c ≥6.5% (≥48 mmol mol
had a self-reported change in body weight >5 kg within 3 months before screeninghad a previous planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year before screening)had or planned to have endoscopic and/or device-based therapy for obesity or had device removal within the past 6 months before screening:mucosal ablationgastric artery embolizationintragastric balloonduodenal–jejunal endoluminal liner
had renal impairment measured as eGFR < 30 ml minhad a known clinically important gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction) or chronically took drugs that directly affect GI motilityhad a history of chronic or acute pancreatitishad thyroid-stimulating hormone (TSH) outside of the range 0.4–6.0 mIU lNote: participants receiving treatment for hypothyroidism may have been included, provided their thyroid hormone replacement dose had been stable for at least 3 months and their TSH at screening fell within the range indicated above.Note: participants with a history of subclinical hypothyroidism but a TSH at screening within the range indicated above may have been included if, in the investigator’s opinion, the patient was unlikely to require initiation of thyroid hormone replacement during the course of the study.had obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency or Prader–Willi syndrome)had a history of substantial active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder or other serious mood or anxiety disorder) within the past 2 yearsNote: participants with MDD or generalized anxiety disorder and whose disease state was considered stable for the past 2 years and was expected to remain stable throughout the course of the study, in the opinion of the investigator, may have been considered for inclusion if they were not on excluded medicationshad a lifetime history of suicide attempthad a PHQ-9 score of 15 or more at visit 1on the Columbia Suicide Severity Rating Scale (C-SSRS) at any time from visit 1 to visit 2:a ‘yes’ answer to Question 4 (active suicidal ideation with some intent to act, without specific plan) on the ‘Suicidal Ideation’ portion of the C-SSRSora ‘yes’ answer to Question 5 (active suicidal ideation with specific plan and intent) on the ‘Suicidal Ideation’ portion of the C-SSRSora ‘yes’ answer to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the ‘Suicidal Behavior’ portion of the C-SSRSandthe ideation or behavior occurred within the past monthhad uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg)had any of the following cardiovascular conditions within 3 months before visit 2:acute myocardial infarctioncerebrovascular accident (stroke)unstable anginahospitalization due to congestive heart failurehad New York Heart Association Functional Classification Class IV congestive heart failurehad acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD) or any of the following, as determined by the central laboratory during screening:alanine aminotransferase level >3.0 times upper limit of normal (ULN) for the reference rangealkaline phosphatase level >1.5 times ULN for the reference rangetotal bilirubin level >1.2 times ULN for the reference range (except for cases of known Gilbert syndrome)Note: participants with NAFLD were eligible to participate in this trial if their alanine aminotransferase level was ≤3.0 times ULN for the reference range.had a serum calcitonin level (at visit 1) of≥20 ng l≥35 ng lhad a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2had a history of an active or untreated malignancy or were in remission from a clinically important malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix or in situ prostate cancer) for <5 yearshad any other condition not listed in this section (for example, hypersensitivity or intolerance) that is a contraindication to GLP-1 R agonistshad a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder or other psychiatric disorder) that, in the opinion of the investigator, may have precluded the participant from following and completing the protocolhad a history of use of marijuana or tetrahydrocannabinol-containing products within 3 months of enrollment, or unwillingness to abstain from marijuana or tetrahydrocannabinol-containing products use during the trialNote: if a participant had used cannabidiol oil during the past 3 months but agreed to refrain from use for the duration of the study, the participant could be enrolled.had had a transplanted organ (corneal transplants (keratoplasty) were allowed) or were awaiting an organ transplanthad any hematological condition that may have interfered with HbA1c measurement (for example, hemolytic anemias, sickle cell disease)
were receiving or had received within 3 months before screening chronic (>2 weeks or 14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular or inhaled preparations) or had evidence of a substantial, active autoimmune abnormality (for example, lupus or rheumatoid arthritis) that had required (within the past 3 months) or was likely to require, in the opinion of the investigator, concurrent treatment with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra-articular or inhaled preparations) during the course of the studyhad current treatment with or history of (within 3 months before visit 2) treatment with medications that may cause substantial weight gain, including but not limited to: tricyclic antidepressants, atypical antipsychotics and mood stabilizersExamples:imipramineamitriptylinemirtazapineparoxetinephenelzinechlorpromazinethioridazineclozapineolanzapinevalproic acid (and its derivatives) orlithiumNote: selective serotonin reuptake inhibitors other than paroxetine were permitted.had taken, within 3 months before visit 2, medications (prescribed or over-the-counter) or alternative remedies that promote weight lossExamples included, but were not limited toSaxenda (liraglutide 3.0 mg)Xenical/Alli (orlistat)Meridia (sibutramine)Acutrim (phenylpropanolamine)Sanorex (mazindol)Apidex (phentermine)BELVIQ (lorcaserin)Bontril (phendimetrazine)Qsymia (phentermine/topiramate combination)Contrave (naltrexone/bupropion)Note: use of metformin, or any other glucose-lowering medication, whether prescribed for polycystic ovarian syndrome or diabetes prevention, was not permitted.had started implantable or injectable contraceptives (such as Depo Provera) within 18 months before screening