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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Zovaglutide in Adults With Overweight or Obesity.

This study will evaluate the percentage change in body weight from baseline and proportion of subjects achieving ≥ 5% weight loss from baseline after 52 weeks of treatment with Zovaglutide in subjects with overweight/obesity.

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:

  1. BMI≥28kg/m²regardless of comorbidities；
  2. 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.