A Study of Zovaglutide in Subjects With Overweight or Obesity (HORIZON-1)
ConditionOverweight , Obesity
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing QL Biopharmaceutical Co.,Ltd
About this trial
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 criteria
Qualifiers
1. Male or female subjects aged≥18years and≤75 years at the time of signing the ICF.
BMI≥28kg/m²regardless of comorbidities；
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%.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Zovaglutide dose 1
- Zovaglutide dose 2
- Placebo
Treatment groups
744 Participants
are divided into 3 treatment groupsLocations
25Xuancheng People's Hospital242099, XuanchengAnhui, China
Gansu Provincial Hospital730099, LanzhouGansu, China
Guangzhou Red Cross Hospital510235, GuangzhouGuangdong, China
Huizhou Central People's Hospital516008, HuizhouGuangdong, China
Sponsors and collaborators
Beijing QL Biopharmaceutical Co.,Ltd
Lead sponsor
Source ClinicalTrials.gov