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.

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