Efficacy and Safety of ZT006 in Overweight and Obese Participants

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Various Doses of ZT006 in Overweight and Obese Participants

This study is being conducted to evaluate the efficacy and safety of ZT006 tablet in participants with overweight and obesity.

In addition to dietary caloric restriction and increased physical activity, study participants will receive either ZT006 tablets or placebo tablets once every morning (placebo looks like ZT006 tablets but has no active pharmaceutical ingredients). For a fair comparison, study participants are assigned to ZT006 or placebo randomly by a computer.

The study consists of a main study and an extension period. The treatment of the main study will last for 28 weeks. ZT006 tablets will be administered daily in an up-titration fashion, i.e. the dose of ZT006 will be gradually increased to reach three target doses (low, medium, high) so that the participants can tolerate its effect. Participants will have 17 clinic visits including one screening visit and one follow-up visit.

The extension study will be conducted only in participants assigned to the low and medium dose groups in the main study. The treatment of the extension period will be 12 weeks.

Female participants who are pregnant, breast-feeding or who plan to become pregnant during the study are not allowed to participate in the study. Pregnancy will be checked by blood or urine tests during the study.

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight , Obesity
• Intervention / Treatment: Drug: ZT006; Drug: Placebo of ZT006; Drug: ZT006

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
    • Peking University People's Hospital
  • Hebei
    • Handan, Hebei, China, 056002
      • Handan First Hospital
    • Langfang, Hebei, China, 065000
      • Hebei Petro China Central Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Harbin Medical University Affiliated Fourth Hospital
  • Henan
    • Luoyang, Henan, China, 471002
      • Luoyang Third People's Hospital
  • Hunan
    • Chenzhou, Hunan, China
      • The First People's Hospital of Chenzhou
    • Yueyang, Hunan, China, 414022
      • YueYang People's Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210003
      • The Second Affiliated Hospital of Nanjing Medical University
  • Shandong
    • Jinan, Shandong, China, 250000
      • Central Hospital Affiliated to Shandong First Medical University
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • First Hospital of Shanxi Medical University
    • Xi’an, Shanxi, China, 710000
      • Xi'an Daxing Hospital
  • Zhejiang
    • Huzhou, Zhejiang, China
      • Huzhou Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

MAIN STUDY:

Inclusion Criteria:

• Male or female, age between 18 - 65 years (both inclusive) at the time of signing of the informed consent.
• Body mass index (BMI) greater than or equal to 28 kg/m², or greater than or equal to 24 kg/m²with at least one of the comorbidities: hypertension, hyperlipidemia, pre-diabetes, metabolic dysfunction-associated steatotic liver disease (MASLD) or obstructive sleep apnea-hypopnea syndrome (OSAHS).
• Having dietary caloric restriction and increased physical activity for ≥3 months, with change in body weight (increase or decrease) no more than 5%, irrespective of medical records.

Exclusion Criteria:

• Type 1 or type 2 diabetes or other specific types derived from other causes
• Medical history of acute or chronic pancreatitis
• Medical history of cholecystitis, gallstone ≤1 cm, or history of symptomatic gallbladder diseases
• Use of glucagon-like peptide-1 (GLP-1) agonist, dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) or GLP-1/glucagon agonist, or triple GLP-1/GIP/glucagon agonist within 90 days before screening
• HbA1c ≥ 6.5% or fasting plasma glucose ≥ 7.0 mmol/L at screening
• Triglyceride ≥ 5.7 mmol/L at screening
• Calcitonin ≥ 50 ng/L at screening

EXTENSION PERIOD:

Inclusion Criteria:

• Assigned to low/medium target dose groups in the main study and having completed week 28 visit in the main study
• Administration of low/medium target dose ≥ 10 times in the last two weeks in the main study

Exclusion Criteria:

• Participation in the dense PK sampling in the main study
• BMI ≤18.5 kg/m² at week 28 visit in the main study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZT006 tablet low target dose; administered per os, daily	Drug: ZT006; Participants will receive a daily dose of ZT006; Drug: ZT006; Participants will receive a weekly dose of ZT006
Experimental: ZT006 tablet medium target dose; administered per os, daily	Drug: ZT006; Participants will receive a daily dose of ZT006; Drug: ZT006; Participants will receive a weekly dose of ZT006
Experimental: ZT006 tablet high target dose; administered per os, daily	Drug: ZT006; Participants will receive a daily dose of ZT006; Drug: ZT006; Participants will receive a weekly dose of ZT006
Placebo Comparator: placebo of ZT006; administered per os, daily	Drug: Placebo of ZT006; Participants will receive a daily dose of placebo of ZT006
Experimental: ZT006 tablet weekly dose 1; administered per os, weekly	Drug: ZT006; Participants will receive a daily dose of ZT006; Drug: ZT006; Participants will receive a weekly dose of ZT006
Experimental: ZT006 tablet weekly dose 2; administered per os, weekly	Drug: ZT006; Participants will receive a daily dose of ZT006; Drug: ZT006; Participants will receive a weekly dose of ZT006

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight relative to baseline	Percentage-point	Percentage-point from baseline to end of treatment (week 28)of the main study
Rate of treatment-emergent adverse events in the extension period	Summarized from adverse event reporting in %	From week 28 to week 45
Rate of serious adverse events in the extension period	Summarized from adverse event reporting in %	From week 28 to week 45

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who achieved body weight reduction greater than or equal to 5% at week 28	Proportion of participants in %	From baseline to end of treatment in the main study (week 28)
Proportion of participants who achieved body weight reduction greater than or equal to 10% at week 28	Proportion of participants in %	From baseline to end of treatment in the main study (week 28)
Proportion of participants who achieved body weight reduction greater than or equal to 15% at week 28	Proportion of participants in %	From baseline to end of treatment in the main study(week 28)
Change in body weight	Measured in kg	From baseline to end of treatment in the main study (week 28)
Change in waist circumference	Measured in cm	From baseline to end of treatment in the main study (week 28)
Change in body mass index (BMI)	Measured in kg/m²（ Body weight in kilogram divided by the square of height in meter ）	From baseline to end of treatment in the main study (week 28)
Rate of treatment-emergent adverse events	Summarized from adverse event reporting in %	From baseline to end of the main study (week 33)
Rate of serious adverse events	Summarized from adverse event reporting in %	From baseline to end of the main study (week 33)
Proportion of participants with positive anti-ZT006 antibody	Summarized in %	From baseline to end of treatment in the main study (week 33)
Change in body weight relative to baseline in the extension period	Percentage point	From week 28 to week 40
Change in body weight	Measured in kg	From week 28 to week 40

Collaborators and Investigators

• Sponsor: Beijing QL Biopharmaceutical Co.,Ltd
• Investigators: Principal Investigator: Linong Ji, MD, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2025
• Primary Completion (Estimated): December 12, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: BJQL-ZT006-2001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No