A Study Evaluating Safety and Tolerability of Switching From Semaglutide to Zovaglutide in Adults With Obesity (HORIZON-SWITCH-SZ)
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)
1 other identifier
interventional
210
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 obesity
Started Oct 2026
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2026
CompletedFirst Posted
Study publicly available on registry
September 10, 2026
CompletedStudy Start
First participant enrolled
October 12, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2028
Study Completion
Last participant's last visit for all outcomes
March 24, 2028
September 10, 2026
September 1, 2026
1.3 years
August 31, 2026
September 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
from week 20 (randomization) to week 36
Secondary Outcomes (5)
Proportion of participants achieving successful switch without severe gastrointestinal adverse event (GIAE)
from week 20 (randomization) to week 36
Proportion of participants achieving successful switch without dose modification
from week 20 (randomization) to week 36
Incidence of GIAE
from week 20 (randomization) to week 40
Percentage of GIAE-free duration relative to total period after randomization
from week 20 (randomization) to week 40
Changes in body weight from randomization
from week 20 （ randomization) to week 36
Study Arms (3)
zovaglutide Arm1
EXPERIMENTALParticipants will receive zovaglutide dosing schedule 1 after randomization.
zovaglutide Arm2
EXPERIMENTALParticipants will receive zovaglutide dosing schedule 2 after randomization.
semaglutide Arm
ACTIVE COMPARATORParticipants will receive semaglutide once weekly after randomization
Interventions
Zovaglutide will be administered via subcutaneous (SC) injection.
Zovaglutide will be administered via subcutaneous (SC) injection.
Eligibility Criteria
You may qualify if:
- 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%.
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Huizhou Central People's Hospital
Huizhou, Guangdong, 516008, China
Handan First Hospital
Handan, Hebei, 056002, China
Hebei Petro China Cental Hospital
Langfang, Hebei, 065000, China
Harbin Medical University Affiliated Fourth Hospital
Harbin, Heilongjiang, 150001, China
The First Affiliated of Nanyang Medical College
Nanyang, Henan, 473000, China
Yichang Central People's Hospital (Xiling Campus)
Yichang, Hubei, 443000, China
The First People's Hospital of Changde
Changde, Hunan, 415003, China
Jilin Province FAW General Hospital
Changchun, Jilin, 130011, China
The Fifth People's Hospital of Shenyang
Shenyang, Liaoning, 110023, China
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250000, China
Zibo Central Hospital
Zibo, Shandong, 255036, China
Zibo Municipal Hospital
Zibo, Shandong, 255400, China
Jincheng General Hospital
Jincheng, Shanxi, 48006, China
The 2nd People's Hospital of Chengdu
Chengdu, Sichuan, 610021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linong Ji, Doctor
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Masking Description
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2026
First Posted
September 10, 2026
Study Start (Estimated)
October 12, 2026
Primary Completion (Estimated)
January 13, 2028
Study Completion (Estimated)
March 24, 2028
Last Updated
September 10, 2026
Record last verified: 2026-09