Diabetes drug shows promise for weight loss in Real-World study
NCT ID NCT06427083
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study is looking at whether enavogliflozin, a diabetes medication, can help people with type 2 diabetes lose weight. Researchers will track 200 adults over 24 weeks in regular doctor visits. The main goal is to see changes in body weight and BMI, along with safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Enavogliflozin (a diabetes drug that helps lower blood sugar and may aid weight loss)
- What this could lead to
- If successful, this could show that enavogliflozin is a safe and effective option for weight loss in people with type 2 diabetes, potentially improving overall disease management.
- What could go wrong
- This is an observational registry study, not a controlled trial, so results may be less reliable. Weight loss effects may be modest, and individual results can vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
200 people
The number who actually took part.
- Started
-
Jun 2024
- Expected to finish
-
Jun 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The mean and standard deviation of the change from baseline to 12 or 24 weeks in weight and body mass index (BMI) from previously conducted Phase 2 and Phase 3 clinical trials were used as references for calculation using G\*Power 3.1.9.7.
- Ages
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19 to 80 years
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adults aged 19 to 80 years. 2. Patients with Type 2 diabetes who are scheduled to receive initial treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the attending physician's medical judgment, within the following insurance coverage ranges: * Enavogliflozin monotherapy * Combination therapy of Enavogliflozin with two agents (metformin) * Combination therapy of Enavogliflozin with three agents (metformin + DPP-4 inhibitor) 3. Patients with obesity beyond the pre-obesity stage according to the 2022 Korean Endocrine Society obesity treatment guidelines: * Pre-obesity stage: BMI 23\~24.9 kg/m2 * Stage 1 obesity: BMI 25\~29.9 kg/m2 * Stage 2 obesity: BMI 30\~34.9 kg/m2 * Stage 3 obesity: BMI ≥ 35 kg/m2 4. Individuals planning to undertake appropriate exercise and dietary therapy for glycemic control during the observational study period. 5. Fertile women and men who agree to contraception according to appropriate contraceptive methods during the observational study period or have no plans for pregnancy, adhering to methods such as hormonal contraceptives, intrauterine devices or systems, tubal ligation, vasectomy, dual contraception methods (such as cervical cap and male condom), etc. 6. Individuals who have received detailed explanation and have understood the nature of the observational study and the investigational drug, and have provided written consent to participate voluntarily in the observational study and to comply with subject precautions during the study period. Exclusion Criteria: 1. Individuals with diabetes other than Type 2 diabetes (Type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.). 2. Individuals contraindicated for Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the approved indications: * Patients with a history of hypersensitivity reactions to the components of Enavogliflozin or Enavogliflozin Extended-Release Tablets * Patients with an eGFR (estimated Glomerular Filtration Rate) less than 30 mL/min/1.73m2, end-stage renal disease, or undergoing dialysis * Patients with moderate to severe hepatic impairment (AST or ALT \> 3 times the upper limit of normal, Total Bilirubin \> 2 times the upper limit of normal, hepatitis or hepatic failure) * Patients classified as NYHA (New York Heart Association) class III or IV 3. Patients initiating treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets at enrollment with an eGFR of less than 60 mL/min/1.73m2. 4. Patients with unstable weight due to treatment with obesity drugs or weight loss medications within 3 months prior to enrollment or other treatments (surgery, dietary therapy, etc.). 5. Individuals with diminished mental capacity. 6. Pregnant and lactating women. 7. Individuals currently participating in another clinical trial and receiving investigational drugs or investigational medical devices. 8. Other individuals deemed unsuitable for participation in the observational study based on the investigator's (attending physician's) judgment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Kyung Hee University Medical Center
Seoul, South Korea
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Other studies related to the condition(s) this trial covers.
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