Efficacy and Safety of ZT006 in Overweight and Obese Participants

NCT07230132 · tracked via the Priya Life Science China tracker

Sponsor

Beijing QL Biopharmaceutical Co.,Ltd

Phase

Phase 2

Started

2025-12-12

Last updated

2026-06-12

Condition(s) studied

Overweight , Obesity

Investigational drug(s) / intervention(s)

ZT006Placebo of ZT006ZT006ZT006ZT006ZT006

ZT006: Participants will receive a daily dose of ZT006

Placebo of ZT006: Participants will receive a daily dose of placebo of ZT006

ZT006: Participants will receive a weekly dose of ZT006

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (12)

Facility	City	Region
Handan First Hospital	Handan	Hebei
Hebei Petro China Central Hospital	Langfang	Hebei
Harbin Medical University Affiliated Fourth Hospital	Harbin	Heilongjiang
Luoyang Third People's Hospital	Luoyang	Henan
The First People's Hospital of Chenzhou	Chenzhou	Hunan
YueYang People's Hospital	Yueyang	Hunan
The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
Central Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
First Hospital of Shanxi Medical University	Taiyuan	Shanxi
Xi'an Daxing Hospital	Xi’an	Shanxi
Huzhou Central Hospital	Huzhou	Zhejiang
Peking University People's Hospital	Beijing	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07230132 on ClinicalTrials.gov ↗ ← All trials in China