Ireland
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Active, not recruiting Phase 3

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

NCT07230119 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2026-01-16
Last updated
2026-08-03

Condition(s) studied

Overweight , Obesity

Investigational drug(s) / intervention(s)

Zovaglutide dose 1 →Zovaglutide dose 2 →Placebo

Zovaglutide dose 1: administered subcutaneously (SC), Q4W

Zovaglutide dose 2: administered subcutaneously (SC), Q4W

Placebo: administered subcutaneously (SC), Q4W

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in body weight(%) — baseline (week 0) to week 52
  • Proportion of subjects achieving ≥ 5% weight loss — 52 weeks

Trial sites (45)

FacilityCityRegionStatus
Xuancheng People's Hospital Xuancheng Anhui
Beijing Friendship Hospital, Capital Medical University Beijing Beijiing
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality
Gansu Provincial Hospital Lanzhou Gansu
Guangzhou Red Cross Hospital Guangzhou Guangdong
Huizhou Central People's Hospital Huizhou Guangdong
The Second Affiliated Hospotal of Guangxi Medical University Nanning Guangxi
Handan First Hospital Handan Hebei
Hebei Petro China Cental Hospital Langfang Hebei
First Hospital of Qinhuangdao Qinhuangdao Hebei
The Second Hospital of Hebei Medical University Shijiangzhuang Hebei
Harbin Medical University Affiliated Fourth Hospital Harbin Heilongjiang
The First Affiliated Hospital of Henan University of Science & Technology Luoyang Henan
Luoyang Third People's Hospital Luoyang Henan
The First Affiliated of Nanyang Medical College Nanyang Henan
Nanyang Second People's Hospital Nanyang Henan
Sanmenxia Central Hospital Sanmenxia Henan
Wuhan No.3 Hospital Wuhan Hubei
Yichang Central People's Hospital (Xiling Campus) Yichang Hubei
Yichang Central People's Hospital Yichang Hubei
The First People's Hospital of Changde Changde Hunan
Yueyang Central Hospital Yueyang Hunan
Yueyang People's Hospital Yueyang Hunan
Zhuzhou Central Hospital Zhuzhou Hunan
The Second People's Hospital of Lianyungang Lianyungang Jiangsu
Nanjing Jiangning Hospital Nanjing Jiangsu
The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
Jiangxi Provincial People's Hospital Nanchang Jiangxi
Jilin Province FAW General Hospital Changchun Jilin
The Third Affiliated Hospital of Jinzhou Medical University Jinzhou Liaoning
The Fifth People's Hospital of Shenyang Shenyang Liaoning
Binzhou Medical University Hospital Binzhou Shandong
Central Hospital Affiliated to Shandong First Medical University Jinan Shandong
Zibo Central Hospital Zibo Shandong
Zibo Municipal Hospital Zibo Shandong
Jincheng General Hospital Jincheng Shanxi
Xi'an Daxing Hospital Xi’an Shanxi
Yan'an University Xianyang Hospital Yanan Shanxi
Yuncheng Central Hospital Yuncheng Shanxi

+ 5 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07230119 on ClinicalTrials.gov ↗ ← All trials in China