NCT04855292

A Study of TG103 Injection in Overweight/Obese Subjects Without Diabetes

A Randomized, Double-blind, Placebo-controlled, Multiple Dose Phase Ib Study in Overweight/Obese Subjects Without Diabetes to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of TG103 Injection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to assess the safety and tolerability of multiple doses of TG103 injection in overweight/obese subjects without diabetes

Detailed description

This study is a randomized, double-blind, placebo-controlled, multiple-doses, parallel-group study to characterize the safety (including the anti-drug antibodies (ADA)), tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TG103 injection. The study will consist of 3 periods: an approximately 4-week screening period, followed by a 12-week treatment period, and a 3-week safety follow-up period. Eligible subjects will be enrolled into three paralleled dose groups (15 mg, 22.5 mg and 30 mg) with 16 subjects in each group. Within each group, subjects will be randomized in a 3:1 ratio to receive TG103 injection or placebo subcutaneously (SC) once a week (QW) over a period of 12 weeks. Each group will be started at a low dose of 7.5 mg and gradually up-titrated at weekly intervals until the target dose.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	TG103 injection	TG103 injection, SC, once weekly
DRUG	Placebo	Placebo control, SC, once weekly

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-12-01
• Completion: 2023-01-01
• First posted: 2021-04-22
• Last updated: 2023-06-22

Locations

1 site across 1 country: China