A Study Evaluating Safety and Tolerability of Switching From Semaglutide to Zovaglutide in Adults With Obesity (HORIZON-SWITCH-SZ)

ClinicalTrials.gov ID

NCT07812597

Lead Sponsor

Beijing QL Biopharmaceutical Co.,LtdINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

210Estimated

Last Update Posted

Sep 10, 2026Actual

Start Date

Oct 12, 2026Estimated

Primary Completion Date

Jan 13, 2028Estimated

Completion Date

Mar 24, 2028Estimated

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)

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.

• Obesity

• zovaglutide Arm 1
• zovaglutide Arm 2
• semaglutide

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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%.

Exclusion Criteria:

• 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Beijing QL Biopharmaceutical Co.,LtdINDUSTRY

150656301@qq.com0752-2288848

dzywhf@163.com0310-8635349

399521211@qq.com0316-2073091

hydsynfm1@163.com0451-82579796

13837739967@163.com0377-63328795

Junzeng@live.com15071725423

YF96204@sina.com13807428016

904702637@qq.com13843126186

zhaoyuzhu2022@126.com18842467548

19xiaodong@163.com18678186512

55700894@qq.com0533-7162162

2366787060@qq.com13834920598

junialang@sina.com18040368202

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