Efficacy and Safety of ZT006 in Overweight and Obese Participants

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.

Timeline

Start

2025-12-12

Primary completion

2026-12-12

Completion

2027-03-31

Drugs

Indications