NCT07230132Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 184 (actual)
- First submitted
- 13 Nov 2025
- Start date
- 12 Dec 2025
- Primary completion date
- 12 Dec 2026
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,Ltd
- Diseases
- Obesity
- NCT number
- NCT07230132
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 184
- From 12 Dec 2025 to the primary completion date, 12 Dec 2026
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- 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
Other
- Calcitonin ≥ 50 ng/L at screening
- EXTENSION PERIOD:
- Participation in the dense PK sampling in the main study
- BMI ≤18.5 kg/m² at week 28 visit in the main study
Who the study is looking for
- 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.
- 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
Criteria the registry did not label
- MAIN STUDY:
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First People's Hospital of Chenzhou Coordinator of this site? Confirm its status | Chenzhou | China | Unknown status |
| Handan First Hospital Coordinator of this site? Confirm its status | Handan | China | Unknown status |
| Harbin Medical University Affiliated Fourth Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Huzhou Central Hospital Coordinator of this site? Confirm its status | Huzhou | China | Unknown status |
| Central Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Hebei Petro China Central Hospital Coordinator of this site? Confirm its status | Langfang | China | Unknown status |
| Luoyang Third People's Hospital Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| First Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Xi'an Daxing Hospital Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Yueyang People's Hospital Coordinator of this site? Confirm its status | Yueyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.