Clinical trial
A Study of Zovaglutide in Subjects With Overweight or Obesity (HORIZON-1)
Active, not recruiting · Phase 3 · 1 countries · Registry ID NCT07230119
Active, not recruitingPhase 3Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight , Obesity
Full registry criteria
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.
Treatments and study arms
Zovaglutide dose 1
Drug
administered subcutaneously (SC), Q4W
Zovaglutide dose 2
Drug
administered subcutaneously (SC), Q4W
Placebo
Drug
administered subcutaneously (SC), Q4W
Primary outcomes
Change in body weight(%)baseline (week 0) to week 52
Proportion of subjects achieving ≥ 5% weight loss52 weeks
Study locations
45 locations were listed when this page was built. The first 40 are shown.
Beijing Friendship Hospital, Capital Medical University🇨🇳 Beijing, Beijiing, China
Peking University People's Hospital🇨🇳 Beijing, China
Binzhou Medical University Hospital🇨🇳 Binzhou, Shandong, China
Jilin Province FAW General Hospital🇨🇳 Changchun, Jilin, China
The First People's Hospital of Changde🇨🇳 Changde, Hunan, China
The 2nd People's Hospital of Chengdu🇨🇳 Chengdu, Sichuan, China
The First Affiliated Hospital of Chongqing Medical University🇨🇳 Chongqing, Chongqing Municipality, China
Guangzhou Red Cross Hospital🇨🇳 Guangzhou, Guangdong, China
Handan First Hospital🇨🇳 Handan, Hebei, China
Harbin Medical University Affiliated Fourth Hospital🇨🇳 Harbin, Heilongjiang, China
Huizhou Central People's Hospital🇨🇳 Huizhou, Guangdong, China
Huzhou Central Hospital🇨🇳 Huzhou, Zhejiang, China
Central Hospital Affiliated to Shandong First Medical University🇨🇳 Jinan, Shandong, China
Jincheng General Hospital🇨🇳 Jincheng, Shanxi, China
The Third Affiliated Hospital of Jinzhou Medical University🇨🇳 Jinzhou, Liaoning, China
Hebei Petro China Cental Hospital🇨🇳 Langfang, Hebei, China
Gansu Provincial Hospital🇨🇳 Lanzhou, Gansu, China
The Second People's Hospital of Lianyungang🇨🇳 Lianyungang, Jiangsu, China
Luoyang Third People's Hospital🇨🇳 Luoyang, Henan, China
The First Affiliated Hospital of Henan University of Science & Technology🇨🇳 Luoyang, Henan, China
Jiangxi Provincial People's Hospital🇨🇳 Nanchang, Jiangxi, China
Nanjing Jiangning Hospital🇨🇳 Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University🇨🇳 Nanjing, Jiangsu, China
The Second Affiliated Hospotal of Guangxi Medical University🇨🇳 Nanning, Guangxi, China
Nanyang Second People's Hospital🇨🇳 Nanyang, Henan, China
The First Affiliated of Nanyang Medical College🇨🇳 Nanyang, Henan, China
The First Affiliated Hospital of Ningbo University🇨🇳 Ningbo, Zhejiang, China
First Hospital of Qinhuangdao🇨🇳 Qinhuangdao, Hebei, China
Sanmenxia Central Hospital🇨🇳 Sanmenxia, Henan, China
The Fifth People's Hospital of Shenyang🇨🇳 Shenyang, Liaoning, China
The Second Hospital of Hebei Medical University🇨🇳 Shijiangzhuang, Hebei, China
Wuhan No.3 Hospital🇨🇳 Wuhan, Hubei, China
Xi'an Daxing Hospital🇨🇳 Xi’an, Shanxi, China
Xuancheng People's Hospital🇨🇳 Xuancheng, Anhui, China
The Affiliated Hospital of Xuzhou Medical University🇨🇳 Xuzhou, Jiangsu, China
Yan'an University Xianyang Hospital🇨🇳 Yanan, Shanxi, China
The Second People's Hospital of Yibin🇨🇳 Yibin, Sichuan, China
Yichang Central People's Hospital🇨🇳 Yichang, Hubei, China
Yichang Central People's Hospital (Xiling Campus)🇨🇳 Yichang, Hubei, China
Yueyang Central Hospital🇨🇳 Yueyang, Hunan, China