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Completed

NCT Number: NCT07020884

A Study of ZT002 Injection With Subjects With Overweight or Obesity

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Handan First Hospital, Handan, Hebei, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZT002 Injection

Drug

Administered SC

ZT002 Placebo

Drug

Administered SC

Primary outcomes

  1. The percentage change from baseline in weight after 24 weeks of treatment.

    Time frame: 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;

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Beijing QL Biopharmaceutical Co.,Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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