A Study of Zovaglutide in Subjects With Overweight or Obesity (HORIZON-1)
NCT ID: NCT07230119
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
744 participants
INTERVENTIONAL
2026-03-08
2027-06-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Zovaglutide dose 1
administered subcutaneously (SC), Q4W
Zovaglutide dose 1
administered subcutaneously (SC), Q4W
Zovaglutide dose 2
administered subcutaneously (SC), Q4W
Zovaglutide dose 2
administered subcutaneously (SC), Q4W
Placebo
Administered subcutaneously (SC), Q4W
Placebo
administered subcutaneously (SC), Q4W
Interventions
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Zovaglutide dose 1
administered subcutaneously (SC), Q4W
Zovaglutide dose 2
administered subcutaneously (SC), Q4W
Placebo
administered subcutaneously (SC), Q4W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Beijing QL Biopharmaceutical Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Linong Ji, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Xuancheng People's Hospital
Xuancheng, Anhui, China
Gansu Provincial Hospital
Lanzhou, Gansu, China
Guangzhou Red Cross Hospital
Guangzhou, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
The Second Affiliated Hospotal of Guangxi Medical University
Nanning, Guangxi, China
Handan First Hospital
Handan, Hebei, China
Hebei Petro China Cental Hospital
Langfang, Hebei, China
First Hospital of Qinhuangdao
Qinhuangdao, Hebei, China
The Second Hospital of Hebei Medical University
Shijiangzhuang, Hebei, China
The Fourth Affiliated Hospital Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Luoyang Third People's Hospital
Luoyang, Henan, China
The First Affiliated of Nanyang Medical College
Nanyang, Henan, China
Nanyang Second People's Hospital
Nanyang, Henan, China
Yichang Central People's Hospital
Yichang, Hubei, China
Yueyang People's Hospital
Yueyang, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Zibo Municipal Hospital
Zibo, Shandong, China
Xi'an Daxing Hospital
Xi’an, Shanxi, China
Peking University People's Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Chongbing Huang, Master
Role: primary
Jinyang Wang, Doctor
Role: primary
Jianmin Ran, Doctor
Role: primary
Shu Li Li, Doctor
Role: primary
Yuzhen Liang, Doctor
Role: primary
Lihun Zhang, Master
Role: primary
Junjie Shang, Master
Role: primary
Chaoyang Zeng, Doctor
Role: primary
Dijun Zhou, Doctor
Role: primary
Lihua Zhou, Doctor
Role: primary
Haixia Wen, Doctor
Role: primary
Yibing Lu, Doctor
Role: primary
Hongwei Ling, Doctor
Role: primary
Linong Ji, MD
Role: primary
Other Identifiers
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BJQL-ZT002-3001
Identifier Type: -
Identifier Source: org_study_id