Overweight , Obesity
Conditions
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.
Interventions
DRUGZT006
Participants will receive a daily dose of ZT006
DRUGPlacebo of ZT006
Participants will receive a daily dose of placebo of ZT006
Sponsors
Beijing QL Biopharmaceutical Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 in % |
| 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 in % |
| 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) | Proportion of participants in % |
| Change in body weight | From baseline to end of treatment in the main study (week 28) | Measured in kg |
| Change in waist circumference | From baseline to end of treatment in the main study (week 28) | Measured in cm |
| Change in body mass index (BMI) | From baseline to end of treatment in the main study (week 28) | Measured in kg/m²（ Body weight in kilogram divided by the square of height in meter ） |
| Rate of treatment-emergent adverse events | From baseline to end of the main study (week 33) | Summarized from adverse event reporting in % |
| Rate of serious adverse events | From baseline to end of the main study (week 33) | Summarized from adverse event reporting in % |
| Proportion of participants with positive anti-ZT006 antibody | From baseline to end of treatment in the main study (week 33) | Summarized in % |
| Change in body weight relative to baseline in the extension period | From week 28 to week 40 | Percentage point |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLinong Ji, MD
Peking University People's Hospital
Outcome results
None listed