A Study of Zovaglutide in Subjects With Overweight or Obesity (HORIZON-1)

Inclusion criteria

• 1. Male or female subjects aged≥18years and≤75 years at the time of signing the ICF.
• 2.At screening and prior to randomization, BMI must meet one of the following criteria:

• BMI≥28kg/m²regardless of comorbidities；
• BM≤24 kg/m² and<28 kg/m², with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver disease, obstructive sleep apnea syndrome due to overweight, or weight-bearing joint pain.
• 3.Weight change due to diet and exercise alone within 3 months prior to screening and randomization did not exceed 5%.

Exclusion criteria

• 1.Previously diagnosed obesity caused by monogenic mutations, other diseases, or medications.
• 2.Previous diagnosis of diabetes; or HbA1c ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L at screening.
• 3.Used of medicines or treatments that affect weight within 3 months prior to screening.
• 4.History of acute or chronic pancreatitis, or pancreatic injury.
• 5.History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.
• 6.History of depression/anxiety disorder, or prior diagnosis of moderate-to-severe anxiety/depressive state, or history of severe psychiatric disorders;
• 7. PHQ-9 scale score is ≥ 15 at screening;
• 8. Screening C-SSRS questionnaire suicide ideation response of "Category 4 or 5," or any "yes" response to suicidal behavior questions.