ObesePhase 4NCT06216340
Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes
A Phase 4 study testing Henagliflozin in people with Obese and Weight Loss, run by The First People's Hospital of Changzhou.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obese, Weight Loss, Pre-diabetes
- What is being tested?
- Henagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 1 Oct 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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;
Show all 26Show fewer
- 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;
- Females of child-bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) within 24 months;
- Participation in a clinical trial within the last 3 months prior to screening;
- Previous history of gestational diabetes;
- Previous history of eating disorders;
- Current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium);
- Diet attempts using herbal supplements or over-the-counter medications within 3 months before screening
- Any lifetime history of a suicidal attempt or a history of any suicidal behavior in the last month prior to randomization;
- Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the investigator
- Known or suspected abuse of alcohol or narcotics
- Subjects from the same house hold participating in the trial
- Other situations which were inappropriate to the trial, at the discretion of the investigator
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
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.
Read the detailed description
Primary Hypothesis:
The 12-week henagliflozin taking could induce significantly higher weight loss in obese subjects without diabetes, compared to diet-exercise therapy.
Assessment time points:
Baseline: prior to taking henagliflozin or diet-exercise therapy V1: 4 weeks following the henagliflozin taking or diet-exercise therapy V2: 4 weeks following V1 V3: 4 weeks following V2
Specific Aims 1:
To examine and compare the weight loss, assessed by weight, waist circumference, hip circumference and BMI, after 12-week henagliflozin taking or diet-exercise therapy in obese without diabetes.
Specific Aims 2:
To examine and compare the change of glucose level after 12-week henagliflozin taking or diet-exercise therapy in obese without diabetes.
Secondary Hypothesis 1:
The 24-week henagliflozin taking could siginificantly improve the glucose control in obese subjects with pre-diabetes, compared to diet-exercise therapy.
Assessment time points:
Baseline: prior to taking henagliflozin or diet-exercise therapy V4: 12 weeks following V3
Specific Aims:
To examine and compare the change of glucose level, assessed by fasting plasma glucose (FPG), postprandial plasma glucose (PPG), HbA1c, insulin levels, after 24-week henagliflozin taking or diet-exercise therapy.
- Conditions
- Obese, Weight Loss, Pre-diabetes
- Being tested
- Henagliflozin, Placebo
- Keywords
- Henagliflozin, Obese, Weight loss, Glucose
- Medical subject headings
- Obesity, Weight Loss, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HenagliflozinDrug
Also called diet-exercise therapy
10mg of Henagliflozin and diet-exercise therapy
PlaceboDrug
Also called diet-exercise therapy
Placebo and diet-exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Placebo and diet-exercise therapy Receives: Drug: Placebo |
| Intervention group | Experimental | 10mg of Henagliflozin and diet-exercise therapy Receives: Drug: Henagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Proportion of weight change from baseline
Measured: 3 months (12 weeks)
Secondary outcomes (2)
Proportion of ≥5% weight loss
Proportion of patients who lost at least 5% of their body weight from baseline
Measured: 3 months (12 weeks)
Incident diabetes
New-onset diabetes during follow up
Measured: 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), 12 months (48 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start15 Feb 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Nanjing Medical University, The First Affiliated Hospital of Soochow University, Second Affiliated Hospital of Soochow University, Wuxi People's Hospital, Northern Jiangsu People's Hospital, The Affiliated Hospital of Xuzhou Medical University, The First People's Hospital of Lianyungang, Affiliated Hospital of Jiangsu University, The fourth affiliated hospital of nantong university
- Responsible party
- Sponsor
- Investigators
- Ling Yang, MD, Principal investigator, Affiliated Hospital of Jiangsu UniversityYu Liu, PHD, Principal investigator, Nanjing Medical UniversityBimin Shi, PHD, Principal investigator, First affiliated hospital of soochow universityJi Hu, Principal investigator, Second Affiliated Hospital of Soochow UniversityXiaowei Zhu, PHD, Principal investigator, Wuxi People's HospitalZhenwen Zhang, PHD, Principal investigator, Northern Jiangsu People's HospitalHongwei Ling, MD, Principal investigator, The Affiliated Hospital of Xuzhou Medical UniversityNing Xu, Bachelor, Principal investigator, The First People's Hospital of Lianyungang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216340
- Sponsor's protocol ID
- 2023-science-150
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data in the current study arisen from a dataset of Department of Endocrine and Metabolic Diseases, the First People's Hospital of Changzhou, Third Affiliated Hospital of Soochow University, are not publicly available due to security consideration, but are available from the corresponding author on reasonable request.
Publications
WHO Guidelines on Physical Activity and Sedentary Behaviour. Geneva: World Health Organization; 2020. Available from http://www.ncbi.nlm.nih.gov/books/NBK566045/
PubMed 33369898Wang 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.
PubMed 16652128Wang 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.
PubMed 31401995Wang 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.
PubMed 34097869Garvey 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.
PubMed 27472012American 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.
PubMed 34964875
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06216340
- Acronym / sponsor ID
- 2023-science-150
- Conditions
- Obese, Weight Loss, Pre-diabetes
- Keywords
- Henagliflozin, Obese, Weight loss, Glucose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Collaborators
- The Second Hospital of Nanjing Medical University, The First Affiliated Hospital of Soochow University, Second Affiliated Hospital of Soochow University, Wuxi People's Hospital, Northern Jiangsu People's Hospital, The Affiliated Hospital of Xuzhou Medical University, The First People's Hospital of Lianyungang, Affiliated Hospital of Jiangsu University, The fourth affiliated hospital of nantong university
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Hypothesis:
The 12-week henagliflozin taking could induce significantly higher weight loss in obese subjects without diabetes, compared to diet-exercise therapy.
Assessment time points:
Baseline: prior to taking henagliflozin or diet-exercise therapy V1: 4 weeks following the henagliflozin taking or diet-exercise therapy V2: 4 weeks following V1 V3: 4 weeks following V2
Specific Aims 1:
To examine and compare the weight loss, assessed by weight, waist circumference, hip circumference and BMI, after 12-week henagliflozin taking or diet-exercise therapy in obese without diabetes.
Specific Aims 2:
To examine and compare the change of glucose level after 12-week henagliflozin taking or diet-exercise therapy in obese without diabetes.
Secondary Hypothesis 1:
The 24-week henagliflozin taking could siginificantly improve the glucose control in obese subjects with pre-diabetes, compared to diet-exercise therapy.
Assessment time points:
Baseline: prior to taking henagliflozin or diet-exercise therapy V4: 12 weeks following V3
Specific Aims:
To examine and compare the change of glucose level, assessed by fasting plasma glucose (FPG), postprandial plasma glucose (PPG), HbA1c, insulin levels, after 24-week henagliflozin taking or diet-exercise therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: PlaceboPlacebo and diet-exercise therapy |
| Intervention group | Experimental | Drug: Henagliflozin10mg of Henagliflozin and diet-exercise therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 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
Key exclusion criteria (26 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HenagliflozinAlso: diet-exercise therapy10mg of Henagliflozin and diet-exercise therapy | Drug | Intervention group |
| PlaceboAlso: diet-exercise therapyPlacebo and diet-exercise therapy | Drug | Control group |
Primary outcome
Weight change
Time frame: 3 months (12 weeks)
Proportion of weight change from baseline
2 secondary outcomes
Proportion of ≥5% weight loss
Time frame: 3 months (12 weeks)
Incident diabetes
Time frame: 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), 12 months (48 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Background: PubMed 33369898WHO Guidelines on Physical Activity and Sedentary Behaviour. Geneva: World Health Organization; 2020. Available from http://www.ncbi.nlm.nih.gov/books/NBK566045/
- Background: PubMed 16652128Wang 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.
- Background: PubMed 31401995Wang 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.
- Background: PubMed 34097869Wang 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.
- Background: PubMed 27472012Garvey 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.
- Results publication: PubMed 34964875American 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.
- Individual participant dataSharing planned: No. The data in the current study arisen from a dataset of Department of Endocrine and Metabolic Diseases, the First People's Hospital of Changzhou, Third Affiliated Hospital of Soochow University, are not publicly available due to security consideration, but are available from the corresponding author on reasonable request.
Related trials for Obese
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Yang, MD principal investigator
Affiliated Hospital of Jiangsu University
Yu Liu, PHD principal investigator
Nanjing Medical University
Bimin Shi, PHD principal investigator
First affiliated hospital of soochow university
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Henagliflozin in people with Obese and Weight Loss, run by The First People's Hospital of Changzhou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Hua, PHD (+86-0519-68876242, huafei1970@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: 3 months (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06216340, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.