Overweight , ObesityPhase 3NCT07230119
A Study of Zovaglutide in Subjects With Overweight or Obesity (HORIZON-1)
A Phase 3 study testing Zovaglutide dose 1 and Zovaglutide dose 2 in people with Overweight , Obesity, run by Beijing QL Biopharmaceutical Co.,Ltd at 45 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight , Obesity
- What is being tested?
- Zovaglutide dose 1 and Zovaglutide dose 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 755 participants
- Where
- 45 sitesChina
- Study dates
- 16 Jan 2026to 26 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- 3.Weight change due to diet and exercise alone within 3 months prior to screening and randomization did not exceed 5%.
Who cannot join
- 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.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
China45 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijiing, 100050
Peking University People's Hospital
Beijing
Binzhou Medical University Hospital
Binzhou, Shandong, 256603
Jilin Province FAW General Hospital
Changchun, Jilin, 130011
The First People's Hospital of Changde
Changde, Hunan, 415003
The 2nd People's Hospital of Chengdu
Chengdu, Sichuan, 610021
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Guangzhou Red Cross Hospital
Guangzhou, Guangdong, 510235
Handan First Hospital
Handan, Hebei, 056002
Harbin Medical University Affiliated Fourth Hospital
Harbin, Heilongjiang, 150001
Huizhou Central People's Hospital
Huizhou, Guangdong, 516008
Huzhou Central Hospital
Huzhou, Zhejiang, 313000
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250000
Jincheng General Hospital
Jincheng, Shanxi, 48006
The Third Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121002
Hebei Petro China Cental Hospital
Langfang, Hebei, 065000
Gansu Provincial Hospital
Lanzhou, Gansu, 730099
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222002
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471000
Luoyang Third People's Hospital
Luoyang, Henan, 471002
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 210000
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
The Second Affiliated Hospotal of Guangxi Medical University
Nanning, Guangxi, 530006
The First Affiliated of Nanyang Medical College
Nanyang, Henan, 473000
Nanyang Second People's Hospital
Nanyang, Henan, 473009
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000
Sanmenxia Central Hospital
Sanmenxia, Henan, 472000
The Fifth People's Hospital of Shenyang
Shenyang, Liaoning, 110023
The Second Hospital of Hebei Medical University
Shijiangzhuang, Hebei, 050005
Wuhan No.3 Hospital
Wuhan, Hubei, 430060
Xi'an Daxing Hospital
Xi’an, Shanxi, 710000
Xuancheng People's Hospital
Xuancheng, Anhui, 242099
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006
Yan'an University Xianyang Hospital
Yanan, Shanxi, 712000
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000
Yichang Central People's Hospital (Xiling Campus)
Yichang, Hubei, 443000
Yichang Central People's Hospital
Yichang, Hubei, 443003
Yueyang Central Hospital
Yueyang, Hunan, 414000
Yueyang People's Hospital
Yueyang, Hunan, 414022
Yuncheng Central Hospital
Yuncheng, Shanxi, 44099
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007
Zibo Central Hospital
Zibo, Shandong, 255036
Zibo Municipal Hospital
Zibo, Shandong, 255400
About this study
Official title: 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.
- Conditions
- Overweight , Obesity
- Being tested
- Zovaglutide dose 1, Zovaglutide dose 2, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zovaglutide dose 1Drug
Also called ZT002 Injection
administered subcutaneously (SC), Q4W
Zovaglutide dose 2Drug
Also called ZT002 Injection
administered subcutaneously (SC), Q4W
PlaceboDrug
administered subcutaneously (SC), Q4W
| Study group | Role | What they receive |
|---|---|---|
| Zovaglutide dose 1 | Experimental | administered subcutaneously (SC), Q4W Receives: Drug: Zovaglutide dose 1 |
| Zovaglutide dose 2 | Experimental | administered subcutaneously (SC), Q4W Receives: Drug: Zovaglutide dose 2 |
| Placebo | Placebo comparator | Administered subcutaneously (SC), Q4W Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight(%)
Measured: baseline (week 0) to week 52
Proportion of subjects achieving ≥ 5% weight loss
Measured: 52 weeks
Secondary outcomes (11)
Proportion of subjects achieving ≥10% weight loss
Measured: week 52
Proportion of subjects achieving ≥15% weight loss.
Measured: week 52
Proportion of subjects achieving ≥20% weight loss.
Measured: week 52
Change in body weight (kg)
Measured: Baseline (week 0) to week 52
Change in BMI (kg/m²)
Measured: Baseline (week 0) to week 52
Change in waist circumference (cm)
Measured: Baseline (week 0) to week 52
Change in hip circumference (cm)
Measured: Baseline (week 0) to week 52
Number of Treatment Emergent Adverse Events (TEAEs)
Measured: Baseline (week 0) to week 56
Number of Serious Adverse Events (SAEs)
Measured: Baseline (week 0) to week 56
Positive rate of anti-drug antibodies (ADA).
Measured: Baseline (week 0) to week 56
Positive rate of neutralizing antibodies (Nab)
Measured: Baseline (week 0) to week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start16 Jan 2026
- Primary completion29 May 2027 (estimated)
- Study completion26 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 755 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linong Ji, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230119
- Sponsor's protocol ID
- BJQL-ZT002-3001
- Status last verified
- Jul 2026
- First submitted
- 13 Nov 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07230119
- Acronym / sponsor ID
- BJQL-ZT002-3001
- Conditions
- Overweight , Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 755 participants (actual)
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 29 May 2027 (estimated)
- Study completion
- 26 Jun 2027 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zovaglutide dose 1 | Experimental | Drug: Zovaglutide dose 1administered subcutaneously (SC), Q4W |
| Zovaglutide dose 2 | Experimental | Drug: Zovaglutide dose 2administered subcutaneously (SC), Q4W |
| Placebo | Placebo comparator | Drug: PlaceboAdministered subcutaneously (SC), Q4W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- 3.Weight change due to diet and exercise alone within 3 months prior to screening and randomization did not exceed 5%.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zovaglutide dose 1Also: ZT002 Injectionadministered subcutaneously (SC), Q4W | Drug | Zovaglutide dose 1 |
| Zovaglutide dose 2Also: ZT002 Injectionadministered subcutaneously (SC), Q4W | Drug | Zovaglutide dose 2 |
| Placeboadministered subcutaneously (SC), Q4W | Drug | Placebo |
Primary outcome
Change in body weight(%)
Time frame: baseline (week 0) to week 52
Proportion of subjects achieving ≥ 5% weight loss
Time frame: 52 weeks
11 secondary outcomes
Proportion of subjects achieving ≥10% weight loss
Time frame: week 52
Proportion of subjects achieving ≥15% weight loss.
Time frame: week 52
Proportion of subjects achieving ≥20% weight loss.
Time frame: week 52
Change in body weight (kg)
Time frame: Baseline (week 0) to week 52
Change in BMI (kg/m²)
Time frame: Baseline (week 0) to week 52
Change in waist circumference (cm)
Time frame: Baseline (week 0) to week 52
Change in hip circumference (cm)
Time frame: Baseline (week 0) to week 52
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline (week 0) to week 56
Number of Serious Adverse Events (SAEs)
Time frame: Baseline (week 0) to week 56
Positive rate of anti-drug antibodies (ADA).
Time frame: Baseline (week 0) to week 56
Positive rate of neutralizing antibodies (Nab)
Time frame: Baseline (week 0) to week 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linong Ji, MD principal investigator
Peking University People's Hospital
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zovaglutide dose 1 and Zovaglutide dose 2 in people with Overweight , Obesity, run by Beijing QL Biopharmaceutical Co.,Ltd at 45 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight(%) (time frame: baseline (week 0) to week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.