Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes

NCT06216340 | Not Yet Recruiting Phase 4

• 1 other identifier: 2023-science-150
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Henagliflozin; Obese; Weight loss; Glucose

Outcome Measures

Primary Outcomes (1)

• Weight change

  Proportion of weight change from baseline

  3 months (12 weeks)

Secondary Outcomes (2)

• Proportion of ≥5% weight loss

  3 months (12 weeks)

• Incident diabetes

  1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), 12 months (48 weeks)

Other Outcomes (15)

• Absolute weight change

  3 months (12 weeks)

• BMI change

  3 months (12 weeks)

• Change of waist circumference

  3 months (12 weeks)

Study Arms (2)

Control group

PLACEBO COMPARATOR

Placebo and diet-exercise therapy

Drug: Placebo

Intervention group

EXPERIMENTAL

10mg of Henagliflozin and diet-exercise therapy

Drug: Henagliflozin

Interventions

Henagliflozin DRUG

10mg of Henagliflozin and diet-exercise therapy

Also known as: diet-exercise therapy

Intervention group

Placebo DRUG

Placebo and diet-exercise therapy

Also known as: diet-exercise therapy

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old≤age≤65 years old, regardless of gender and race
• Nondiabetic population: without hypoglycemic treatment, FPG\<7.0 mmol/l, PPG\<11.1 mmol/l, and HbA1c\<6.5%
• obesity: BMI≥28 kg/m2
• Stable weight: weight change less than 5kg in the past 3 months
• Ability to understand and sign the informed consent form

You may not qualify if:

• Allergies to Henagliflozin or its formulations;
• Participants have been definitely diagnosed with diabetes;
• HbA1c≥6.5 % or FPG≥7.0 mmol/l, or PPG≥11.1 mmol/l;
• Participants have used glucagon-like peptide-1 (GLP-1) receptor agonists, sodium glucose linked transporter-2 (SGLT-2) inhibitors, or other weight loss related drugs within the past 3 months;
• History of bariatric surgery;
• Untreated or uncontrolled hypothyroidism/hyperthyroidism;
• High risk of urinary tract infection;
• Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome);
• Diagnosis of congenital glucose-galactose malabsorption or familial renal glycosuria
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 times the upper limit of the normal range (UNL); Total bilirubin (TBIL) ≥ 2.0 times the upper limit of the normal range;
• estimated glomerular filtration rate (eGFR)\<30 mL/min/1.73 m2 or end-stage kidney disease, or requiring dialysis;
• History of major depressive disorder or other severe psychiatric disorders, e.g. schizophrenia, bipolar disorder within the last 2 years;
• Uncontrolled treated/untreated hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg)
• myocardial infarction, unstable angina, revascularization surgery, or cerebrovascular diseases within the past 3 months;
• Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer) or other severe diseases, which in the investigator's opinion could interfere with the results of the trial;

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead
• The Second Hospital of Nanjing Medical University: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• Wuxi People's Hospital: collaborator
• Northern Jiangsu People's Hospital: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• The First People's Hospital of Lianyungang: collaborator
• Affiliated Hospital of Jiangsu University: collaborator
• The fourth affiliated hospital of nantong university: collaborator

Related Publications (6)

• WHO Guidelines on Physical Activity and Sedentary Behaviour. Geneva: World Health Organization; 2020. Available from http://www.ncbi.nlm.nih.gov/books/NBK566045/

  PMID: 33369898 BACKGROUND

• Wang Y, Mi J, Shan XY, Wang QJ, Ge KY. Is China facing an obesity epidemic and the consequences? The trends in obesity and chronic disease in China. Int J Obes (Lond). 2007 Jan;31(1):177-88. doi: 10.1038/sj.ijo.0803354. Epub 2006 May 2.

  PMID: 16652128 BACKGROUND

• Wang Y, Xue H, Sun M, Zhu X, Zhao L, Yang Y. Prevention and control of obesity in China. Lancet Glob Health. 2019 Sep;7(9):e1166-e1167. doi: 10.1016/S2214-109X(19)30276-1. No abstract available.

  PMID: 31401995 BACKGROUND

• Wang Y, Zhao L, Gao L, Pan A, Xue H. Health policy and public health implications of obesity in China. Lancet Diabetes Endocrinol. 2021 Jul;9(7):446-461. doi: 10.1016/S2213-8587(21)00118-2. Epub 2021 Jun 4.

  PMID: 34097869 BACKGROUND

• Garvey WT, Mechanick JI, Brett EM, Garber AJ, Hurley DL, Jastreboff AM, Nadolsky K, Pessah-Pollack R, Plodkowski R; Reviewers of the AACE/ACE Obesity Clinical Practice Guidelines. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY COMPREHENSIVE CLINICAL PRACTICE GUIDELINES FOR MEDICAL CARE OF PATIENTS WITH OBESITYEXECUTIVE SUMMARYComplete Guidelines available at https://www.aace.com/publications/guidelines. Endocr Pract. 2016 Jul;22(7):842-84. doi: 10.4158/EP161356.ESGL.

  PMID: 27472012 BACKGROUND

• American Diabetes Association Professional Practice Committee. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022 Jan 1;45(Suppl 1):S17-S38. doi: 10.2337/dc22-S002.

  PMID: 34964875 RESULT

MeSH Terms

Conditions

Obesity; Weight Loss; Glucose Intolerance

Interventions

henagliflozin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Ling Yang, MD

  Affiliated Hospital of Jiangsu University

  PRINCIPAL INVESTIGATOR

• Yu Liu, PHD

  Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Bimin Shi, PHD

  First affiliated hospital of soochow university

  PRINCIPAL INVESTIGATOR

• Ji Hu

  Second Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

• Xiaowei Zhu, PHD

  Wuxi People's Hospital

  PRINCIPAL INVESTIGATOR

• Zhenwen Zhang, PHD

  Northern Jiangsu People's Hospital

  PRINCIPAL INVESTIGATOR

• Hongwei Ling, MD

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

• Ning Xu, Bachelor

  The First People's Hospital of Lianyungang

  PRINCIPAL INVESTIGATOR

• Yanmei Liu, MD

  YANCHENG NO.1 PEOPLE'S HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Hua, PHD

CONTACT

+86-0519-68876242; huafei1970@suda.edu.cn

Xiaolin Huang, PHD

CONTACT

+86-0519-68876242; hxl4038@czfph.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and care providers are all masked. Investigators randomly cluster the participants, and the actual mask of the participant is not available to care providers and the participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly divided into two groups: control group and intervention group. In control group, Placebo and diet-exercise therapy is used. In intervention group, 10mg of henagliflozin and diet-exercise therapy is used.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 22, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share