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

July 31, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
755

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Peking University People's Hospital
    • Anhui
      • Xuancheng, Anhui, China, 242099
        • Xuancheng People's Hospital
    • Beijiing
      • Beijing, Beijiing, China, 100050
        • Beijing Friendship hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University
    • Gansu
      • Lanzhou, Gansu, China, 730099
        • GanSu Provincial Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510235
        • Guangzhou Red Cross Hospital
      • Huizhou, Guangdong, China, 516008
        • Huizhou Central People's Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530006
        • The Second Affiliated Hospotal of Guangxi Medical University
    • 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
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Harbin Medical University Affiliated Fourth Hospital
    • 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
      • Nanyang, Henan, China, 473000
        • The First Affiliated of Nanyang Medical College
      • Sanmenxia, Henan, China, 472000
        • Sanmenxia Central Hospital
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Wuhan No.3 Hospital
      • Yichang, Hubei, China, 443003
        • Yichang Central People's Hospital
      • Yichang, Hubei, China, 443000
        • Yichang Central People's Hospital (Xiling Campus)
    • Hunan
      • Changde, Hunan, China, 415003
        • The First People's Hospital of Changde
      • Yueyang, Hunan, China, 414000
        • Yueyang Central Hospital
      • Yueyang, Hunan, China, 414022
        • Yueyang People's Hospital
      • Zhuzhou, Hunan, China, 412007
        • Zhuzhou Central Hospital
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222002
        • The Second People's Hospital of Lianyungang
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Nanjing, Jiangsu, China, 210000
        • Nanjing Jiangning Hospital
      • Xuzhou, Jiangsu, China, 221006
        • The Affiliated Hospital of Xuzhou Medical University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial People's Hospital
    • Jilin
      • Changchun, Jilin, China, 130011
        • Jilin Province FAW General Hospital
    • Liaoning
      • Jinzhou, Liaoning, China, 121002
        • The Third Affiliated Hospital of Jinzhou Medical University
      • Shenyang, Liaoning, China, 110023
        • The Fifth People's Hospital of Shenyang
    • Shandong
      • Binzhou, Shandong, China, 256603
        • Binzhou Medical University Hospital
      • Jinan, Shandong, China, 250000
        • Central Hospital Affiliated to Shandong First Medical University
      • Zibo, Shandong, China, 255036
        • Zibo Central Hospital
      • Zibo, Shandong, China, 255400
        • Zibo Municipal Hospital
    • Shanxi
      • Jincheng, Shanxi, China, 48006
        • Jincheng General Hospital
      • Xi’an, Shanxi, China, 710000
        • Xi'an Daxing Hospital
      • Yanan, Shanxi, China, 712000
        • Yan'an University Xianyang Hospital
      • Yuncheng, Shanxi, China, 44099
        • Yuncheng Central Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610021
        • The 2nd People's Hospital of Chengdu
      • Yibin, Sichuan, China, 644000
        • The Second People's Hospital of Yibin
    • Zhejiang
      • Huzhou, Zhejiang, China, 313000
        • Huzhou Central Hospital
      • Ningbo, Zhejiang, China, 315010
        • The First Affiliated Hospital of Ningbo University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing QL Biopharmaceutical Co.,Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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