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A Study of Zovaglutide in Subjects With Overweight or Obesity (HORIZON-1)

Active Not RecruitingPhase 3

Sponsor: Beijing QL Biopharmaceutical Co.,Ltd

Conditions: Overweight , Obesity

Interventions: Zovaglutide dose 1, Zovaglutide dose 2, Placebo

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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:

  1. BMI≥28kg/m²regardless of comorbidities；
  2. 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%.

Exclusion Criteria:

* 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.

Locations (45)

Xuancheng, Anhui, China
Beijing, Beijiing, China
Chongqing, Chongqing Municipality, China
Lanzhou, Gansu, China
Guangzhou, Guangdong, China
Huizhou, Guangdong, China
Nanning, Guangxi, China
Handan, Hebei, China
Langfang, Hebei, China
Qinhuangdao, Hebei, China
Shijiangzhuang, Hebei, China
Harbin, Heilongjiang, China
Luoyang, Henan, China
Luoyang, Henan, China
Nanyang, Henan, China
Nanyang, Henan, China
Sanmenxia, Henan, China
Wuhan, Hubei, China
Yichang, Hubei, China
Yichang, Hubei, China
Changde, Hunan, China
Yueyang, Hunan, China
Yueyang, Hunan, China
Zhuzhou, Hunan, China
Lianyungang, Jiangsu, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Xuzhou, Jiangsu, China
Nanchang, Jiangxi, China
Changchun, Jilin, China
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