Efficacy and Safety of ZT006 in Overweight and Obese Participants

Beijing QL Biopharmaceutical

Status and phase: Not yet enrolling; Phase 2

Conditions: Overweight , Obesity

Treatments: Drug: Placebo of ZT006; Drug: ZT006

Study type: Interventional

Funder types: Industry

Identifiers

NCT07230132

BJQL-ZT006-2001

Details and patient eligibility

About

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 treatment will last for 28 weeks. ZT006 tablets will be administered in an up-titration fashion, i.e. the dose of ZT006 will be gradually increased to reach three target doses so that the participants can tolerate its effect. Participants will have 17 clinic visits including one screening visit and one follow-up visit.

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 4 patient groups, including a placebo group

ZT006 tablet low target dose

Experimental group

Description:

administered per os, daily

Treatment:

Drug: ZT006

ZT006 tablet medium target dose

Experimental group

Description:

administered per os, daily

Treatment:

Drug: ZT006

ZT006 tablet high target dose

Experimental group

Description:

administered per os, daily

Treatment:

Drug: ZT006

placebo of ZT006

Placebo Comparator group

Description:

administered per os, daily

Treatment:

Drug: Placebo of ZT006