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

Beijing QL Biopharmaceutical

Status and phase: Begins enrollment this month; Phase 3

Conditions: Overweight , Obesity

Treatments: Drug: Zovaglutide dose 2; Drug: Zovaglutide dose 1; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07230119

BJQL-ZT002-3001

Details and patient eligibility

About

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.

Enrollment: 744 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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744 participants in 3 patient groups, including a placebo group

Zovaglutide dose 1

Experimental group

Description:

administered subcutaneously (SC), Q4W

Treatment:

Drug: Zovaglutide dose 1

Zovaglutide dose 2

Experimental group

Description:

administered subcutaneously (SC), Q4W

Treatment:

Drug: Zovaglutide dose 2

Placebo

Placebo Comparator group

Description:

Administered subcutaneously (SC), Q4W

Treatment:

Drug: Placebo