A Study of ZT002 Injection in Participants With Overweight or Obesity

NCT06371326 | Completed Phase 1

• 1 other identifier: BJQLZT002004
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study will comprise a randomized, double-blind, placebo-controlled, multiple-ascending-dose, safety, tolerability, and pharmacokinetics study of ZT002 in participants with Overweight or Obesity.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of a multiple escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in MAD Cohorts. Number of participants with treatment-emergent adverse events.

  up to 270 days

• Safety and tolerability of a multiple escalation dose of ZT002 through the incidence severity of serious adverse events in MAD Cohorts. Number of participants with serious adverse events.

  up to 270 days

Secondary Outcomes (3)

• The Pharmacokinetics (PK) profile of a multiple escalation dose of ZT002 in participants with overweight or obesity.

  up to 270 days

• The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in participants with overweight or obesity.

  up to 270 days

• The anti-drug antibody (ADA) response through testing serum or plasma of the participants post-dosing.

  up to 270 days

Study Arms (2)

ZT002 Injection

EXPERIMENTAL

Participants will be randomized to receive ZT002 injection in 1of 2 dose cohorts.

Drug: ZT002 Injection

ZT002 Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive same volume Placebo in 1 of 2 dose cohorts.

Drug: Placebo

Interventions

ZT002 Injection DRUG

Participants will receive ZT002 by subcutaneous (SC) injection.

ZT002 Injection

Placebo DRUG

Participants will receive Placebo by subcutaneous (SC) injection.

ZT002 Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Males and females aged 18 to 50 years (inclusive, based on age at the time of signing the informed consent form);
• \. BMI ≥ 24 kg/m2 and \< 28 kg/m2 with at least one of the following concomitant disease (pre-diabetes \[except for type 1 or type 2 diabetes\], hypertension, hyperlipidemia, fatty liver, obstructive sleep apnoea syndrome, weight-bearing joint pain, etc., see Appendices I and II) or BMI ≥ 28 kg/m2 and ≤ 40 kg/m2 and with or without concomitant disease;
• \. Weight change of no more than 5% (based on self-report) after 3 months of weight control via diet and exercise alone prior to screening, and the formula for calculating weight change is: (highest weight - lowest weight during 3 months of weight control via diet and exercise alone prior to screening) ∕highest weight\*100%;
• \. Female subjects are required to adopt abstinence or 2 effective methods of contraception from 1 month prior to screening to 6 months after the last dose, and male subjects are required to adopt abstinence or 2 effective methods of contraception from the first dose to 3 months after the last dose. For male subjects, the effective methods of contraception are as follows: surgical sterilization (e.g., vasectomy) or proper use of condoms, or the female partners use hormonal contraceptives (e.g., contraceptive pills, patches, implantable or injectable) or intrauterine devices (IUDs) or surgical sterilization; for female subjects, the effective methods of contraception are as follows: surgical sterilization (e.g., tubal ligation) or use of IUDs, or male partners properly use condoms or are surgically sterilized, in addition, the female subjects are allowed to use the NMPA-approved hormonal contraceptives (e.g., contraceptive pills, patches, implantable or injectable);
• \. Subjects who have a good understanding of study objectives, be able to communicate well with the investigator, and be able to understand and comply with the requirements set forth for this study.

You may not qualify if:

• \. History of specific allergies (asthma, eczema, etc.) or allergic constitution, or history of allergy to two or more drugs and foods, especially to the investigational drug and its excipients or GLP-1-containing drugs;
• \. Previous diagnosis of obesity associated with endocrine disease or single gene mutation, including but not limited to, hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, hypogonadism;
• \. Subjects who have had severe gastrointestinal diseases (e.g., active ulcers) or undergone gastrointestinal surgery (except for appendectomy or cholecystectomy) or have clinically significant abnormalities of gastric emptying (e.g., pyloric obstruction, gastric paralysis) within 6 months prior to screening or have been taking medications that have a direct effect on gastrointestinal motility for a long term, or who are not suitable for participation in the trial as assessed by the investigator;
• \. Prior history of significant cardiovascular disease, defined as:
• a) History of myocardial infarction, coronary angioplasty or bypass grafting, heart valve disease or heart valve repair, clinically significant arrhythmia requiring treatment, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident within 6 months prior to screening; b) New York Heart Association (NYHA) class III or IV congestive cardiac failure;
• \. Uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg;
• \. Laboratory test results at screening meet any of the following criteria (one retest is allowed during the screening period if there is any clear reason, and the investigator should document the reason for retest):
• Glycosylated hemoglobin (HbA1c) ≥ 6.5% or fasting plasma glucose ≥ 7.0 mmol/L, or two-hour plasma glucose ≥ 11.1 mmol/L on oral glucose tolerance test (OGTT) (at screening, subjects with fasting venous plasma glucose between 6.1 and 6.9 mmol/L need to perform OGTT) (see Appendix I, OGTT Test Method);
• Thyroid-stimulating hormone (TSH) \> 6.0 mIU/L or \< 0.4 mIU/L;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 × ULN or blood total bilirubin ≥ 2 × ULN;
• Fasting triglycerides \> 5.65 mmol/L;
• Blood amylase or blood lipase ≥ 1.5 × ULN;
• Calcitonin ≥ 50 ng/L (pg/mL);
• Estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m2, estimated using CKD-EPI formula (see Appendix 3);
• Abnormal 12-lead electrocardiogram (ECG): second- or third-degree atrioventricular block, long QT syndrome or QTcF \> 450 ms (males) or \> 470 ms (females) (see formula in Appendix 4), left or right bundle branch block, pre-excitation syndrome, or other clinically significant arrhythmia (except for sinus arrhythmia);

Sponsors & Collaborators

• Beijing QL Biopharmaceutical Co.,Ltd: lead

Study Sites (1)

First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoli Li, Master

  First Affiliated Hospital of Bengbu Medical College

  PRINCIPAL INVESTIGATOR

• Huan Zhou, PhD

  First Affiliated Hospital of Bengbu Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 17, 2024
• Study Start: November 21, 2023
• Primary Completion: April 15, 2024
• Study Completion: October 17, 2024
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

CN (1)