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.
1 other identifier
interventional
744
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2026
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2025
CompletedFirst Posted
Study publicly available on registry
November 17, 2025
CompletedStudy Start
First participant enrolled
March 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 26, 2027
December 23, 2025
December 1, 2025
1.2 years
November 13, 2025
December 17, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in body weight(%)
baseline (week 0) to week 52
Proportion of subjects achieving ≥ 5% weight loss
52 weeks
Secondary Outcomes (11)
Proportion of subjects achieving ≥10% weight loss
week 52
Proportion of subjects achieving ≥15% weight loss.
week 52
Proportion of subjects achieving ≥20% weight loss.
week 52
Change in body weight (kg)
Baseline (week 0) to week 52
Change in BMI (kg/m²)
Baseline (week 0) to week 52
- +6 more secondary outcomes
Study Arms (3)
Zovaglutide dose 1
EXPERIMENTALadministered subcutaneously (SC), Q4W
Zovaglutide dose 2
EXPERIMENTALadministered subcutaneously (SC), Q4W
Placebo
PLACEBO COMPARATORAdministered subcutaneously (SC), Q4W
Interventions
administered subcutaneously (SC), Q4W
administered subcutaneously (SC), Q4W
Eligibility Criteria
You may qualify if:
- \. Male or female subjects aged≥18years and≤75 years at the time of signing the ICF.
- 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.
- Weight change due to diet and exercise alone within 3 months prior to screening and randomization did not exceed 5%.
You may not qualify if:
- Previously diagnosed obesity caused by monogenic mutations, other diseases, or medications.
- Previous diagnosis of diabetes; or HbA1c ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L at screening.
- Used of medicines or treatments that affect weight within 3 months prior to screening.
- History of acute or chronic pancreatitis, or pancreatic injury.
- History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.
- History of depression/anxiety disorder, or prior diagnosis of moderate-to-severe anxiety/depressive state, or history of severe psychiatric disorders;
- \. PHQ-9 scale score is ≥ 15 at screening;
- \. Screening C-SSRS questionnaire suicide ideation response of "Category 4 or 5," or any "yes" response to suicidal behavior questions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Xuancheng People's Hospital
Xuancheng, Anhui, 242099, China
Gansu Provincial Hospital
Lanzhou, Gansu, 730099, China
Guangzhou Red Cross Hospital
Guangzhou, Guangdong, 510235, China
Huizhou Central People's Hospital
Huizhou, Guangdong, 516008, China
The Second Affiliated Hospotal of Guangxi Medical University
Nanning, Guangxi, 530006, China
Handan First Hospital
Handan, Hebei, 056002, China
Hebei Petro China Cental Hospital
Langfang, Hebei, 065000, China
First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000, China
The Second Hospital of Hebei Medical University
Shijiangzhuang, Hebei, 050005, China
The Fourth Affiliated Hospital Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471000, China
Luoyang Third People's Hospital
Luoyang, Henan, 471002, China
The First Affiliated of Nanyang Medical College
Nanyang, Henan, 473000, China
Nanyang Second People's Hospital
Nanyang, Henan, 473009, China
Yichang Central People's Hospital
Yichang, Hubei, 443003, China
Yueyang People's Hospital
Yueyang, Hunan, 414022, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222002, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 210000, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006, China
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250000, China
Zibo Municipal Hospital
Zibo, Shandong, 255400, China
Xi'an Daxing Hospital
Xi’an, Shanxi, 710000, China
Peking University People's Hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linong Ji, MD
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2025
First Posted
November 17, 2025
Study Start
March 8, 2026
Primary Completion (Estimated)
May 29, 2027
Study Completion (Estimated)
June 26, 2027
Last Updated
December 23, 2025
Record last verified: 2025-12