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

Phase 2

Active, not recruiting

• Conditions: Overweight or Obesity
• Interventions: Drug: ZT002 Injection; Drug: ZT002 Placebo

• Registration Number: NCT07020884
• Lead Sponsor: Beijing QL Biopharmaceutical Co.,Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-14
• Status Verified: 2025-06
• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZT002 Injection dose 1	ZT002 Injection	Dose 1 administered subcutaneously (SC), Q2W
ZT002 Injection dose 2	ZT002 Injection	Dose 2 administered subcutaneously (SC),Q2W
ZT002 Injection dose 3	ZT002 Injection	Dose 3 administered subcutaneously (SC),Q4W
ZT002 Injection dose 4	ZT002 Injection	Dose 4 administered subcutaneously (SC), Q4W
ZT002 Placebo	ZT002 Placebo	administered subcutaneously (SC), Q2W or Q4W

Primary Outcome Measures

Name	Time	Method
The percentage change from baseline in weight after 24 weeks of treatment.	baseline, 24 weeks

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects with weight loss of ≥ 5%, ≥ 10%, and ≥ 15% from baseline after 24 weeks of treatment;	24 weeks

Trial Locations

Locations (16)

Handan First Hospital; 🇨🇳 Handan, Hebei, China

Hebei Petro China Cental Hospital; 🇨🇳 Langfang, Hebei, China

First Hospital of Qinhuangdao; 🇨🇳 Qinhuangdao, Hebei, China

The Fourth Affiliated Hospital Harbin Medical University; 🇨🇳 Ha'erbin, Heilongjiang, China

The First Affiliated Hospital of Henan University of Science & Technology; 🇨🇳 Luoyang, Henan, China

Luoyang Third People's Hospital; 🇨🇳 Luoyang, Henan, China

The First Affiliated of Nanyang Medical College; 🇨🇳 Nanyang, Henan, China

Affiliated Hospital of Jiangsu University; 🇨🇳 Zhenjiang, Jiangsu, China

Zibo Municipal Hospital; 🇨🇳 Zibo, Shandong, China

Xi'an Daxing Hospital; 🇨🇳 Xi'an, Shanxi, China

Peking University First Hospital; 🇨🇳 Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, China

Nanjing Jiangning Hospital; 🇨🇳 Nanjing, Jiangsu, China

Tonghua Central Hospital; 🇨🇳 Tonghua, Jilin, China

Genertec Liaoyou Gem Flower Hospital; 🇨🇳 Panjin, Liaoning, China

Central Hospital Affiliated to Shandong First Medical University; 🇨🇳 Jinan, Shandong, China