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

December 17, 2025 updated by: Beijing QL Biopharmaceutical Co.,Ltd

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

744

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Peking University People's Hospital
        • Contact:
    • Anhui
      • Xuancheng, Anhui, China, 242099
        • Xuancheng People's Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730099
        • Gansu Provincial Hospital
        • Contact:
          • Jinyang Wang, Doctor
    • Guangdong
      • Guangzhou, Guangdong, China, 510235
        • Guangzhou Red Cross Hospital
        • Contact:
          • Jianmin Ran, Doctor
          • Phone Number: 86-20-61883706
          • Email: ranjm@163.com
      • Huizhou, Guangdong, China, 516008
        • Huizhou Central People's Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530006
        • The Second Affiliated Hospotal of Guangxi Medical University
        • Contact:
    • Hebei
      • Handan, Hebei, China, 056002
        • Handan First Hospital
      • Langfang, Hebei, China, 065000
        • Hebei Petro China Cental Hospital
      • Qinhuangdao, Hebei, China, 066000
        • First Hospital of Qinhuangdao
      • Shijiangzhuang, Hebei, China, 050005
        • The Second Hospital of Hebei Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The Fourth Affiliated Hospital Harbin Medical University
    • Henan
      • Luoyang, Henan, China, 471000
        • The First Affiliated Hospital of Henan University of Science & Technology
      • Luoyang, Henan, China, 471002
        • Luoyang Third People's Hospital
      • Nanyang, Henan, China, 473009
        • Nanyang Second People's Hospital
        • Contact:
      • Nanyang, Henan, China, 473000
        • The First Affiliated of Nanyang Medical College
    • Hubei
      • Yichang, Hubei, China, 443003
        • Yichang Central People's Hospital
        • Contact:
    • Hunan
      • Yueyang, Hunan, China, 414022
        • YueYang People's Hospital
        • Contact:
      • Zhuzhou, Hunan, China, 412007
        • ZhuZhou Central Hospital
        • Contact:
          • Lihua Zhou, Doctor
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222002
        • The Second People's Hospital of Lianyungang
        • Contact:
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Nanjing Jiangning Hospital
      • Xuzhou, Jiangsu, China, 221006
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250000
        • Central Hospital Affiliated to Shandong First Medical University
      • Zibo, Shandong, China, 255400
        • Zibo Municipal Hospital
    • Shanxi
      • Xi’an, Shanxi, China, 710000
        • Xi'an Daxing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zovaglutide dose 1
administered subcutaneously (SC), Q4W
Drug: Zovaglutide dose 1
administered subcutaneously (SC), Q4W
Other Names:
  • ZT002 Injection
Experimental: Zovaglutide dose 2
administered subcutaneously (SC), Q4W
Drug: Zovaglutide dose 2
administered subcutaneously (SC), Q4W
Other Names:
  • ZT002 Injection
Placebo Comparator: Placebo
Administered subcutaneously (SC), Q4W
Drug: Placebo
administered subcutaneously (SC), Q4W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in body weight(%)
Time Frame: baseline (week 0) to week 52
baseline (week 0) to week 52
Proportion of subjects achieving ≥ 5% weight loss
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving ≥10% weight loss
Time Frame: week 52
week 52
Proportion of subjects achieving ≥15% weight loss.
Time Frame: week 52
week 52
Proportion of subjects achieving ≥20% weight loss.
Time Frame: week 52
week 52
Change in body weight (kg)
Time Frame: Baseline (week 0) to week 52
Baseline (week 0) to week 52
Change in BMI (kg/m²)
Time Frame: Baseline (week 0) to week 52
Baseline (week 0) to week 52
Change in waist circumference (cm)
Time Frame: Baseline (week 0) to week 52
Baseline (week 0) to week 52
Change in hip circumference (cm)
Time Frame: Baseline (week 0) to week 52
Baseline (week 0) to week 52
Number of Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline (week 0) to week 56
Baseline (week 0) to week 56
Number of Serious Adverse Events (SAEs)
Time Frame: Baseline (week 0) to week 56
Baseline (week 0) to week 56
Positive rate of anti-drug antibodies (ADA).
Time Frame: Baseline (week 0) to week 56
Baseline (week 0) to week 56
Positive rate of neutralizing antibodies (Nab)
Time Frame: Baseline (week 0) to week 56
Baseline (week 0) to week 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing QL Biopharmaceutical Co.,Ltd

Investigators

  • Principal Investigator: Linong Ji, MD, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 8, 2026

Primary Completion (Estimated)

May 29, 2027

Study Completion (Estimated)

June 26, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Estimated)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJQL-ZT002-3001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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