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NOT YET RECRUITING
NCT07826364
PHASE1

A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Study of SHR-1179 Injection in Participants With Obesity

Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

This study is a single-center, randomized, double-blind, dose-escalation, placebo-parallel-controlled Phase I clinical trial. The primary objective is to evaluate the safety and tolerability of a single subcutaneous injection of SHR-1179 in obese participants. For the single-ascending-dose (SAD) part in obese participants, a total of 5 dose cohorts are planned for the single-dose escalation.

Official title: A Randomized, Double-blind, Dose-escalation, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous SHR-1179 Injection in Obese Participants."

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-09

Completion Date

2027-09

Last Updated

2026-09-17

Healthy Volunteers

Yes

Interventions

DRUG

SHR-1179 ; Placebo

Dose 1 SHR-1179+Placebo low dose

DRUG

SHR-1179 ; Placebo

Dose 2 SHR-1179+Placebo low dose

DRUG

SHR-1179 ; Placebo

Dose 3 SHR-1179+Placebo medium dose

DRUG

SHR-1179 ; Placebo

Dose 4 SHR-1179+Placebo high dose

DRUG

SHR-1179 ; Placebo

Dose 5 SHR-1179+Placebo high dose

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China