Clinical trial NCT07020884: A Phase II Study of ZT002 Injection With Subjects With Overweight or Obesity
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Overweight or Obesity
Lead sponsor: Beijing QL Biopharmaceutical Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2025-06-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The percentage change from baseline in weight after 24 weeks of treatment.
timeFrame: baseline, 24 weeks
Secondary outcomes:
measure: The proportion of subjects with weight loss of ≥ 5%, ≥ 10%, and ≥ 15% from baseline after 24 weeks of treatment;
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Handan
country: China
facility: Handan First Hospital
state: Hebei
city: Langfang
country: China
facility: Hebei Petro China Cental Hospital
state: Hebei
city: Qinhuangdao
country: China
facility: First Hospital of Qinhuangdao
state: Hebei
city: Ha'erbin
country: China
facility: The Fourth Affiliated Hospital Harbin Medical University
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science & Technology
state: Henan
city: Luoyang
country: China
facility: Luoyang Third People's Hospital
state: Henan
city: Nanyang
country: China
facility: The First Affiliated of Nanyang Medical College
state: Henan
city: Nanjing
country: China
facility: Nanjing Jiangning Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Tonghua
country: China
facility: Tonghua Central Hospital
state: Jilin
city: Panjin
country: China
facility: Genertec Liaoyou Gem Flower Hospital
state: Liaoning
city: Jinan
country: China
facility: Central Hospital Affiliated to Shandong First Medical University
state: Shandong
city: Zibo
country: China
facility: Zibo Municipal Hospital
state: Shandong
city: Xi'an
country: China
facility: Xi'an Daxing Hospital
state: Shanxi
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Linong Ji, MD
role: PRINCIPAL_INVESTIGATOR
References: