ObesityPhase 2NCT07812597
A Study Evaluating Safety and Tolerability of Switching From Semaglutide to Zovaglutide in Adults With Obesity (HORIZON-SWITCH-SZ)
A Phase 2 study testing zovaglutide Arm 1, zovaglutide Arm 2 and semaglutide in people with Obesity, run by Beijing QL Biopharmaceutical Co.,Ltd at 16 sites in China.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of continuing treatment with zovaglutide injection following titration to 2.4 mg semaglutide injection in adult participants with obesity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- zovaglutide Arm 1, zovaglutide Arm 2 and semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 16 sitesChina
- Study dates
- 12 Oct 2026to 24 Mar 2028
- Phase
- Phase 2
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
- Male or female subjects aged≥18years and≤75 years at the time of signing the Informed Consent Form (ICF).
- At screening, Body Mass Index (BMI)≥28kg/m²
- Weight change due to diet and exercise alone within 3 months prior to screening did not exceed 5%.
Who cannot join
- 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 medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.
- Patient Health Questionnaire-9 (PHQ-9) scale score is ≥ 15 at screening
- Screening Columbia-Suicide Severity Rating Scale(C-SSRS) questionnaire suicide ideation response of "Category 4 or 5," or any "yes" response to suicidal behavior questions
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Linong Ji, Doctor, 010-88324973, jiln@bjmu.edu.cn
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
MingXia Yuan, Doctor, 13910184427, mx.yuan@ccmu.edu.cn
Jilin Province FAW General Hospital
Changchun, Jilin, 130011
Chengwei Song, Doctor, 13843126186, 904702637@qq.com
The First People's Hospital of Changde
Changde, Hunan, 415003
Fang Yu, Doctor, 13807428016, YF96204@sina.com
The 2nd People's Hospital of Chengdu
Chengdu, Sichuan, 610021
Hongmei Lang, Doctor, 18040368202, junialang@sina.com
Handan First Hospital
Handan, Hebei, 056002
Haifang Wang, Master, 0310-8635349, dzywhf@163.com
Harbin Medical University Affiliated Fourth Hospital
Harbin, Heilongjiang, 150001
Zhifeng Cheng, Doctor, 0451-82579796, hydsynfm1@163.com
Huizhou Central People's Hospital
Huizhou, Guangdong, 516008
Shu Li, Doctor, 0752-2288848, 150656301@qq.com
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250000
Nianrong Mi, Doctor, 0531-55865000, 410285342@qq.com
Jincheng General Hospital
Jincheng, Shanxi, 48006
Lili Zhang, Doctor, 13834920598, 2366787060@qq.com
Hebei Petro China Cental Hospital
Langfang, Hebei, 065000
Jie Han, Master, 0316-2073091, 399521211@qq.com
The First Affiliated of Nanyang Medical College
Nanyang, Henan, 473000
Dexue Liu, Master, 0377-63328795, 13837739967@163.com
The Fifth People's Hospital of Shenyang
Shenyang, Liaoning, 110023
Yuzhu Zhao, Doctor, 18842467548, zhaoyuzhu2022@126.com
Yichang Central People's Hospital (Xiling Campus)
Yichang, Hubei, 443000
Jun Zeng, Doctor, 15071725423, Junzeng@live.com
Zibo Central Hospital
Zibo, Shandong, 255036
Xiaodong Zhao, Doctor, 18678186512, 19xiaodong@163.com
Zibo Municipal Hospital
Zibo, Shandong, 255400
Hongyan Shu, Doctor, 0533-7162162, 55700894@qq.com
About this study
Official title: A Multicenter, Randomized, Active-Controlled, Open-Label Phase IIb Study Evaluating Safety and Tolerability of Switching to Zovaglutide Injection After Titration to 2.4 mg Semaglutide Injection (Wegovy®) in Adults With Obesity (HORIZON-SWITCH-SZ)
The main purpose of this study is to evaluate the safety and tolerability of continuing treatment with zovaglutide injection following titration to 2.4 mg semaglutide injection in adult participants with obesity.
- Conditions
- Obesity
- Being tested
- zovaglutide Arm 1, zovaglutide Arm 2, semaglutide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zovaglutide Arm 1Drug
Also called ZT002 Injection
Zovaglutide will be administered via subcutaneous (SC) injection.
zovaglutide Arm 2Drug
Also called ZT002 Injection
Zovaglutide will be administered via subcutaneous (SC) injection.
semaglutideDrug
Semaglutide will be administered via subcutaneous (SC) injection.
| Study group | Role | What they receive |
|---|---|---|
| zovaglutide Arm1 | Experimental | Participants will receive zovaglutide dosing schedule 1 after randomization. Receives: Drug: zovaglutide Arm 1 |
| zovaglutide Arm2 | Experimental | Participants will receive zovaglutide dosing schedule 2 after randomization. Receives: Drug: zovaglutide Arm 2 |
| semaglutide Arm | Active comparator | Participants will receive semaglutide once weekly after randomization Receives: Drug: semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving successful switch from semaglutide 2.4 mg to zovaglutide after randomization
Measure description:Definition of successful switch: Participants administered the target dose of assigned zovaglutide at both week28 and week32.
Measured: from week 20 (randomization) to week 36
Secondary outcomes (5)
Proportion of participants achieving successful switch without severe gastrointestinal adverse event (GIAE)
Measured: from week 20 (randomization) to week 36
Proportion of participants achieving successful switch without dose modification
Measured: from week 20 (randomization) to week 36
Incidence of GIAE
Measured: from week 20 (randomization) to week 40
Percentage of GIAE-free duration relative to total period after randomization
Measured: from week 20 (randomization) to week 40
Changes in body weight from randomization
Measured: from week 20 （ randomization) to week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start12 Oct 2026 (estimated)
- Primary completion13 Jan 2028 (estimated)
- Study completion24 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linong Ji, Doctor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812597
- Sponsor's protocol ID
- BJQL-ZT002-2003
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No