A Phase II Study of ZT002 Injection With Subjects With Overweight or Obesity

Beijing QL Biopharmaceutical

Status and phase: Active, not recruiting; Phase 2

Conditions: Overweight or Obesity

Treatments: Drug: ZT002 Placebo; Drug: ZT002 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07020884

BJQL-ZT002-2001

Details and patient eligibility

About

This study will evaluate the percentage change from baseline in weight after 24 weeks of treatment with ZT002 Injection in subjects with overweight/obesity.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years and ≤ 75 years.
• BMI ≥28 kg/m², or 24 kg/m2 ≤ BMI < 28 kg/m2 with at least one comorbidity (pre-diabetes, hypertension, hyperlipidemia, fatty liver, obstructive sleep apnoea syndrome due to overweight, weight-bearing joint pain, etc.)
• Weight change is not more than 5% with diet and exercise control alone within 3 months prior to screening.

Exclusion criteria

• Previous diagnosis of diabetes; or HbA1c ≥ 6. 5% or fasting blood glucose ≥ 7.0 mmol/L at screening.
• Have used medicines or treatments that affect weight within 3 months prior to screening.
• History of acute or chronic pancreatitis.
• Personal or family (parents, children, and siblings) history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type II (MEN2).
• History of definite mental disease within 2 years prior to screening or prior suicidal tendency or suicidal behavir; or PHQ-9 scale score is ≥ 15 at screening; or C-SSRS questionnaire is either class 4 or 5 at screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 5 patient groups, including a placebo group

ZT002 Injection dose 1

Experimental group

Description:

Dose 1 administered subcutaneously (SC), Q2W

Treatment:

Drug: ZT002 Injection

ZT002 Injection dose 2

Experimental group

Description:

Dose 2 administered subcutaneously (SC),Q2W

Treatment:

Drug: ZT002 Injection

ZT002 Injection dose 3

Experimental group

Description:

Dose 3 administered subcutaneously (SC),Q4W

Treatment:

Drug: ZT002 Injection

ZT002 Injection dose 4

Experimental group

Description:

Dose 4 administered subcutaneously (SC), Q4W

Treatment:

Drug: ZT002 Injection

ZT002 Placebo

Placebo Comparator group

Description:

administered subcutaneously (SC), Q2W or Q4W

Treatment:

Drug: ZT002 Placebo