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 groupsSponsors and collaborators
Source ClinicalTrials.gov