A Study of ZT002 Injection With Subjects With Overweight or Obesity

NCT07020884 — Phase 2, Completed, 303 participants, Beijing QL Biopharmaceutical Co.,Ltd

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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

RegistryNCT07020884
StatusCompleted
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment303 (Actual)
SponsorBeijing QL Biopharmaceutical Co.,Ltd (Industry)
ConditionsOverweight or Obesity
InterventionsZT002 Injection, ZT002 Placebo (Drug)
Datesstart 2024-08-14, primary completion 2025-05-07, completion 2025-05-29, first posted 2025-06-13, last updated 2025-12-10
Locations16 sites in China

Related Papers Related Patents Related Grants Related Experts
All trials for Overweight or Obesity All trials of ZT002 Injection All trials of ZT002 Placebo

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
ZT002 Injection dose 1ExperimentalDrug: ZT002 InjectionDose 1 administered subcutaneously (SC), Q2W
ZT002 Injection dose 2ExperimentalDrug: ZT002 InjectionDose 2 administered subcutaneously (SC),Q2W
ZT002 Injection dose 3ExperimentalDrug: ZT002 InjectionDose 3 administered subcutaneously (SC),Q4W
ZT002 Injection dose 4ExperimentalDrug: ZT002 InjectionDose 4 administered subcutaneously (SC), Q4W
ZT002 PlaceboPlacebo comparatorDrug: ZT002 Placeboadministered subcutaneously (SC), Q2W or Q4W
  • ZT002 Injection (Drug): Administered SC
  • ZT002 Placebo (Drug): Administered SC

+Outcome measures

Primary outcomes

  • The percentage change from baseline in weight after 24 weeks of treatment. [baseline, 24 weeks]

Secondary outcomes

  • The proportion of subjects with weight loss of ≥ 5%, ≥ 10%, and ≥ 15% from baseline after 24 weeks of treatment; [24 weeks]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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.

+Locations (16)

FacilityCityCountryStatus
Handan First HospitalHandan, HebeiChina
Hebei Petro China Cental HospitalLangfang, HebeiChina
First Hospital of QinhuangdaoQinhuangdao, HebeiChina
The Fourth Affiliated Hospital Harbin Medical UniversityHarbin, HeilongjiangChina
The First Affiliated Hospital of Henan University of Science & TechnologyLuoyang, HenanChina
Luoyang Third People's HospitalLuoyang, HenanChina
The First Affiliated of Nanyang Medical CollegeNanyang, HenanChina
Nanjing Jiangning HospitalNanjing, JiangsuChina
Affiliated Hospital of Jiangsu UniversityZhenjiang, JiangsuChina
Tonghua Central HospitalTonghua, JilinChina
Genertec Liaoyou Gem Flower HospitalPanjin, LiaoningChina
Central Hospital Affiliated to Shandong First Medical UniversityJinan, ShandongChina
Zibo Municipal HospitalZibo, ShandongChina
Xi'an Daxing HospitalXi’an, ShanxiChina
Peking University First HospitalBeijingChina
Peking University People's HospitalBeijingChina

+Investigators

  • Linong Ji, MD, Principal investigator, Peking University People's Hospital