CClinicalTrials.gg
Sign In
Active, not recruitingNCT06427083Updated Sep 2, 2025

Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus

An observational study in Type 2 Diabetes Mellitus, sponsored by Daewoong Pharmaceutical Co. LTD.. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
19 Years to 80 Years
Sex
All
01

Study summary

This observational study is designed to assess the effects of Envlo Tablet or Envlomet SR Tablet on weight loss and safety in patients with Type 2 diabetes, conducted in real primary care settings over a period of 24 weeks.

Read the detailed description

The study plans to recruit patients with Type 2 diabetes who are scheduled to receive Envlo Tablet or Envlomet SR Tablet based on the attending physician's medical judgment, regardless of previous diabetes treatment. However, voluntary consent from patients is required for participation in the study, even if Envlo Tablet or Envlomet SR Tablet are prescribed.

Data collection will occur for up to 24 weeks post-Envlo Tablet or Envlomet SR Tablet initiation, capturing demographic information, physical measurements, vital signs, and lifestyle factors. Follow-up visits at 12 weeks and 24 weeks post-baseline will be conducted to collect data, including clinical indicators, safety evaluations, and adverse events. Data will be collected based on routine clinical records, with no mandatory study-specific visits or interventions.

Overall, this observational study aims to collect data on demographics, physical measurements, vital signs, and clinical indicators in patients receiving Envlo Tablet or Envlomet SR Tablet in real-world clinical settings, utilizing information obtained during routine patient care processes.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

9,362 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,317 are open to participants now.

This study's enrollment of 200 is below the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

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.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • patient diagnosed with type2 diabetes mellitus

    patient diagnosed with type2 diabetes mellitus

    Drug: Envlo Tablet · Drug: Envolomet SR Tablet

Interventions

  • DrugEnvlo Tablet

    Enavogliflozin 0.3mg

  • DrugEnvolomet SR Tablet

    Enavogliflozin 0.3mg/Metformin1,000mg

06

What researchers measure

Primary outcomes

  1. change in BMI

    change in BMI at 24 weeks from baseline

    Time frame: 24 weeks

  2. change in body weight

    change in body weight at 24 weeks from baseline

    Time frame: 24 weeks

Secondary outcomes

  1. change in BMI

    change in BMI at 12 weeks from baseline

    Time frame: 12 weeks

  2. change in body weight

    change in body weight at 12 weeks from baseline

    Time frame: 12 weeks

  3. Proportion of subjects achieving ≥ 5% reduction in BMI

    Proportion of subjects achieving ≥ 5% reduction in BMI at 12 weeks compared to baseline

    Time frame: 12 weeks

  4. Proportion of subjects achieving ≥ 5% reduction in BMI

    Proportion of subjects achieving ≥ 5% reduction in BMI at 24 weeks compared to baseline

    Time frame: 24 weeks

  5. Proportion of subjects achieving ≥ 5% reduction in weight

    Proportion of subjects achieving ≥ 5% reduction in weight at 12 weeks compared to baseline

    Time frame: 12 weeks

  6. Proportion of subjects achieving ≥ 5% reduction in weight

    Proportion of subjects achieving ≥ 5% reduction in weight at 24 weeks compared to baseline

    Time frame: 24 weeks

  7. Change in body composition analyzer indicators (body fat mass, visceral fat mass, muscle mass, waist/hip circumference, etc.)

    Change in body composition analyzer indicators (body fat mass, visceral fat mass, muscle mass, waist/hip circumference, etc.) at 12 weeks compared to baseline

    Time frame: 12 weeks

  8. Change in body composition analyzer indicators (body fat mass, visceral fat mass, muscle mass, waist/hip circumference, etc.)

    Change in body composition analyzer indicators (body fat mass, visceral fat mass, muscle mass, waist/hip circumference, etc.) at 24 weeks compared to baseline

    Time frame: 24 weeks

  9. Change in HbA1c

    Change in HbA1c at 12 weeks compared to baseline

    Time frame: 12 weeks

  10. Change in HbA1c

    Change in HbA1c at 24 weeks compared to baseline

    Time frame: 24 weeks

  11. Change in FPG

    Change in FPG at 12 weeks compared to baseline

    Time frame: 12 weeks

  12. Change in FPG

    Change in FPG at 24 weeks compared to baseline

    Time frame: 24 weeks

  13. Proportion of subjects achieving HbA1c < 7%

    Proportion of subjects achieving HbA1c \< 7% at 12 weeks compared to baseline

    Time frame: 12 weeks

  14. Proportion of subjects achieving HbA1c < 7%

    Proportion of subjects achieving HbA1c \< 7% at 24 weeks compared to baseline

    Time frame: 24 weeks

  15. Proportion of subjects achieving HbA1c < 6.5%

    Proportion of subjects achieving HbA1c \< 6.5% at 12 weeks compared to baseline

    Time frame: 12 weeks

  16. Proportion of subjects achieving HbA1c < 6.5%

    Proportion of subjects achieving HbA1c \< 6.5% at 24 weeks compared to baseline

    Time frame: 24 week

  17. Proportion of subjects achieving therapeutic response [change in HbA1c (baseline HbA1c - HbA1c at each evaluation time point) > 0.5% or HbA1c < 7%]

    Proportion of subjects achieving therapeutic response \[change in HbA1c (baseline HbA1c - HbA1c at each evaluation time point) \> 0.5% or HbA1c \< 7%\] at 12 weeks compared to baseline

    Time frame: 12 weeks

  18. Proportion of subjects achieving therapeutic response [change in HbA1c (baseline HbA1c - HbA1c at each evaluation time point) > 0.5% or HbA1c < 7%]

    Proportion of subjects achieving therapeutic response \[change in HbA1c (baseline HbA1c - HbA1c at each evaluation time point) \> 0.5% or HbA1c \< 7%\] at 24 weeks compared to baseline

    Time frame: 24 weeks

07

Study locations

1 site
  • Kyung Hee University Medical Center
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06427083
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
May 23, 2024
Start date
Jun 11, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Sep 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus, Type 2→

Other studies from this sponsor

Daewoong Pharmaceutical Co. LTD.

Start the discussion