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Type 2 Diabetes MellitusNCT06427083

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

An observational study of Type 2 Diabetes Mellitus, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Envlo Tablet and Envolomet SR Tablet
Type of treatment
Pill or oral medicine
How many people
200 participants
Where
1 siteSouth Korea
Study dates
11 Jun 2024to 30 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 19 to 80 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • Adults aged 19 to 80 years.
  • 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)
  • Patients with obesity beyond the pre-obesity stage according to the 2022 Korean Endocrine Society obesity treatment guidelines:
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  • 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
  • Individuals planning to undertake appropriate exercise and dietary therapy for glycemic control during the observational study period.
  • 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.
  • 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.

Who cannot join

  • Individuals with diabetes other than Type 2 diabetes (Type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.).
  • 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
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  • Patients initiating treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets at enrollment with an eGFR of less than 60 mL/min/1.73m2.
  • 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.).
  • Individuals with diminished mental capacity.
  • Pregnant and lactating women.
  • Individuals currently participating in another clinical trial and receiving investigational drugs or investigational medical devices.
  • Other individuals deemed unsuitable for participation in the observational study based on the investigator's (attending physician's) judgment.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kyung Hee University Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: An Anonymized, De-identified Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus

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.

Being tested
Envlo Tablet, Envolomet SR Tablet
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Envlo TabletDrug

    Enavogliflozin 0.3mg

  • Envolomet SR TabletDrug

    Enavogliflozin 0.3mg/Metformin1,000mg

Study groups in NCT06427083
Study groupRoleWhat they receive
patient diagnosed with type2 diabetes mellituspatient diagnosed with type2 diabetes mellitus
Receives: Drug: Envlo Tablet; Drug: Envolomet SR Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in BMI

    change in BMI at 24 weeks from baseline

    Measured: 24 weeks

  2. change in body weight

    change in body weight at 24 weeks from baseline

    Measured: 24 weeks

Secondary outcomes (18)

  1. change in BMI

    change in BMI at 12 weeks from baseline

    Measured: 12 weeks

  2. change in body weight

    change in body weight at 12 weeks from baseline

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 24 weeks

  9. Change in HbA1c

    Change in HbA1c at 12 weeks compared to baseline

    Measured: 12 weeks

  10. Change in HbA1c

    Change in HbA1c at 24 weeks compared to baseline

    Measured: 24 weeks

  11. Change in FPG

    Change in FPG at 12 weeks compared to baseline

    Measured: 12 weeks

  12. Change in FPG

    Change in FPG at 24 weeks compared to baseline

    Measured: 24 weeks

  13. Proportion of subjects achieving HbA1c < 7%

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

    Measured: 12 weeks

  14. Proportion of subjects achieving HbA1c < 7%

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

    Measured: 24 weeks

  15. Proportion of subjects achieving HbA1c < 6.5%

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

    Measured: 12 weeks

  16. Proportion of subjects achieving HbA1c < 6.5%

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

    Measured: 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

    Measured: 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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2024
  2. Study start11 Jun 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06427083
Sponsor's protocol ID
DW_ODNENV_DB_02
Status last verified
Aug 2025
First submitted
14 May 2024
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

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 13 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in BMI (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 NCT06427083.

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 2 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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