A Study of ZT002 Injection With Subjects With Overweight or Obesity
A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of ZT002 Injection in Subjects With Overweight or Obesity
1 other identifier
interventional
303
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2024
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2025
CompletedFirst Submitted
Initial submission to the registry
June 6, 2025
CompletedFirst Posted
Study publicly available on registry
June 13, 2025
CompletedDecember 10, 2025
December 1, 2025
9 months
June 6, 2025
December 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The percentage change from baseline in weight after 24 weeks of treatment.
baseline, 24 weeks
Secondary Outcomes (1)
The proportion of subjects with weight loss of ≥ 5%, ≥ 10%, and ≥ 15% from baseline after 24 weeks of treatment;
24 weeks
Study Arms (5)
ZT002 Injection dose 1
EXPERIMENTALDose 1 administered subcutaneously (SC), Q2W
ZT002 Injection dose 2
EXPERIMENTALDose 2 administered subcutaneously (SC),Q2W
ZT002 Injection dose 3
EXPERIMENTALDose 3 administered subcutaneously (SC),Q4W
ZT002 Injection dose 4
EXPERIMENTALDose 4 administered subcutaneously (SC), Q4W
ZT002 Placebo
PLACEBO COMPARATORadministered subcutaneously (SC), Q2W or Q4W
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Handan First Hospital
Handan, Hebei, 056002, China
Hebei Petro China Cental Hospital
Langfang, Hebei, 065000, China
First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000, China
The Fourth Affiliated Hospital Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471000, China
Luoyang Third People's Hospital
Luoyang, Henan, 471002, China
The First Affiliated of Nanyang Medical College
Nanyang, Henan, 473000, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 210000, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000, China
Tonghua Central Hospital
Tonghua, Jilin, 134000, China
Genertec Liaoyou Gem Flower Hospital
Panjin, Liaoning, 124000, China
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250000, China
Zibo Municipal Hospital
Zibo, Shandong, 255400, China
Xi'an Daxing Hospital
Xi’an, Shanxi, 710000, China
Peking University First Hospital
Beijing, 100044, China
Peking University People's Hospital
Beijing, 100044, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linong Ji, MD
Peking University People's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2025
First Posted
June 13, 2025
Study Start
August 14, 2024
Primary Completion
May 7, 2025
Study Completion
May 29, 2025
Last Updated
December 10, 2025
Record last verified: 2025-12