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

NCT07812597

Not Yet RecruitingPhase 2

Sponsor: Beijing QL Biopharmaceutical Co.,Ltd

Conditions: Obesity

Interventions: zovaglutide Arm 1, zovaglutide Arm 2, semaglutide

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (16)

Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Huizhou, Guangdong, China
Handan, Hebei, China
Langfang, Hebei, China
Harbin, Heilongjiang, China
Nanyang, Henan, China
Yichang, Hubei, China
Changde, Hunan, China
Changchun, Jilin, China
Shenyang, Liaoning, China
Jinan, Shandong, China
Zibo, Shandong, China
Zibo, Shandong, China
Jincheng, Shanxi, China
Chengdu, Sichuan, China