Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes

Summary

This trial is conducted in China. The purpose of the 24-week trial is to investigate the efficacy of henagliflozin to induce body weight loss and the purpose of the extension is to evaluate the hypoglycemic effect of henagliflozin in obese subjects without diabetes.

Trial has the following two periods: 1) A 12-week randomized, double-blind, placebo-controlled, multi-center trial for evaluating the efficacy of henagliflozin to induce body weight loss; 2) A 12-week multicenter randomized controlled open-label trial for evaluating the hypoglycemic effect of henagliflozin followed by a 24-week extension period.

Conditions

• Obese
• Weight Loss
• Pre-diabetes

Interventions

DRUG

Henagliflozin

10mg of Henagliflozin and diet-exercise therapy

DRUG

Placebo

Placebo and diet-exercise therapy

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• Second Affiliated Hospital of Soochow University

  collaborator OTHER

• Wuxi People's Hospital

  collaborator OTHER

• Northern Jiangsu People's Hospital

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• The First People's Hospital of Lianyungang

  collaborator OTHER

• Affiliated Hospital of Jiangsu University

  collaborator OTHER

• The fourth affiliated hospital of nantong university

  collaborator UNKNOWN

• The First People's Hospital of Changzhou

  lead OTHER

Principal Investigators

• Ling Yang, MD · Affiliated Hospital of Jiangsu University

• Yu Liu, PHD · Nanjing Medical University

• Bimin Shi, PHD · First affiliated hospital of soochow university

• Ji Hu · Second Affiliated Hospital of Soochow University

• Xiaowei Zhu, PHD · Wuxi People's Hospital

• Zhenwen Zhang, PHD · Northern Jiangsu People's Hospital

• Hongwei Ling, MD · The Affiliated Hospital of Xuzhou Medical University

• Ning Xu, Bachelor · The First People's Hospital of Lianyungang

• Yanmei Liu, MD · YANCHENG NO.1 PEOPLE'S HOSPITAL

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-15

Primary Completion

2026-10-01

Completion

2026-10-01