Efficacy and Safety of ZT006 in Overweight and Obese Participants

NCT07230132 | Active Not Recruiting Phase 2

• 1 other identifier: BJQL-ZT006-2001
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Overweight , Obesity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Proportion of participants who achieved body weight reduction greater than or equal to 5% at week 28

  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

  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

  From baseline to end of treatment in the main study(week 28)

• Change in body weight

  From baseline to end of treatment in the main study (week 28)

• Change in waist circumference

  From baseline to end of treatment in the main study (week 28)

Study Arms (6)

ZT006 tablet low target dose

EXPERIMENTAL

administered per os, daily

Drug: ZT006

ZT006 tablet medium target dose

EXPERIMENTAL

administered per os, daily

Drug: ZT006

ZT006 tablet high target dose

EXPERIMENTAL

administered per os, daily

Drug: ZT006

placebo of ZT006

PLACEBO COMPARATOR

administered per os, daily

Drug: Placebo of ZT006

ZT006 tablet weekly dose 1

EXPERIMENTAL

administered per os, weekly

Drug: ZT006

ZT006 tablet weekly dose 2

EXPERIMENTAL

administered per os, weekly

Drug: ZT006

Interventions

ZT006 DRUG

Participants will receive a daily dose of ZT006

ZT006 tablet low target dose

Placebo of ZT006 DRUG

Participants will receive a daily dose of placebo of ZT006

placebo of ZT006

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing QL Biopharmaceutical Co.,Ltd: lead

Study Sites (12)

Handan First Hospital

Handan, Hebei, 056002, China

Location

Hebei Petro China Central Hospital

Langfang, Hebei, 065000, China

Location

Harbin Medical University Affiliated Fourth Hospital

Harbin, Heilongjiang, 150001, China

Location

Luoyang Third People's Hospital

Luoyang, Henan, 471002, China

Location

The First People's Hospital of Chenzhou

Chenzhou, Hunan, China

Location

YueYang People's Hospital

Yueyang, Hunan, 414022, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210003, China

Location

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250000, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Xi'an Daxing Hospital

Xi’an, Shanxi, 710000, China

Location

Huzhou Central Hospital

Huzhou, Zhejiang, China

Location

Peking University People's Hospital

Beijing, 100044, 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

• Linong Ji, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: November 13, 2025
• First Posted: November 17, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 12, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

CN (12)