Diabetes, Type 2Phase 4K-Direct2NCT07753447
Calorie Restricted Dietary Intervention in Type 2 Diabetes Patients With Obesity for Remission
A Phase 4 study testing Contrave ER and Low-calorie meal box in people with Diabetes, Type 2 and Obesity &Amp; Overweight, run by Yeouido St. Mary's Hospital at 1 site in South Korea.
Trial summary
This study aims to induce remission of type 2 diabetes through dietary intervention for weight reduction. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Diabetes, Type 2, Obesity &Amp; Overweight
- What is being tested?
- Contrave ER and Low-calorie meal box
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2025to 28 Feb 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged ≥19 and <60 years
- Confirmed diagnosis of type 2 diabetes
- Diagnosed with diabetes within the past 6 years
- Most recent BMI within the past 3 months ≥27 kg/m²
- Most recent HbA1c within the past 3 months <11%
- No insulin therapy within the past 3 months
Who cannot join
- Pregnant women or those who may become pregnant during the study period
- Individuals with organ failure, such as heart failure, hepatic failure, renal failure, or chronic obstructive pulmonary disease
- History of cardiovascular disease or cancer treatment within the past 6 months
- Acute illness requiring hospitalization (e.g., infection or surgery) within the past 3 months
- Presence of endocrine disorders that may affect body weight, such as Cushing's syndrome
- Use of medications (other than glucose-lowering agents for diabetes) known to affect blood glucose levels within the past 6 months
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- Individuals with known food allergies to specific ingredients in the study meals
- Individuals with uncontrolled hypertension
- Individuals with acute alcohol or drug withdrawal symptoms
- History of seizure disorders such as epilepsy
- Individuals with genetic disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to induce remission of type 2 diabetes through dietary intervention for weight reduction.
Read the detailed description
To promote weight loss, nutritionally balanced low-calorie meal boxes (provided by CJ CheilJedang) will be used. For the purpose of setting an active control group, all participants will also receive Contrave Extended-Release tablets (provided by Kwangdong Pharmaceutical), a medication indicated for weight loss.
- Conditions
- Diabetes, Type 2, Obesity &Amp; Overweight
- Being tested
- Contrave ER, Low-calorie meal box
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrave ERDrug
Contrave is an extended-release combination of naltrexone and bupropion, approved for chronic weight management. It acts on the central nervous system to reduce appetite and control food cravings.
Low-calorie meal boxCombination product
The meal boxes provided by CJ CheilJedang are nutritionally-balanced, low-calorie HMR products developed with reduced levels of sodium, sugar, and saturated fats.
| Study group | Role | What they receive |
|---|---|---|
| Contrave ER + Low-calorie Meal Box + Nutritional Intervention | Experimental | Drug: Contrave ER Combination Product: Low-calorie Meal Box Behavioral: Nutritional Intervention Receives: Drug: Contrave ER; Combination Product: Low-calorie meal box |
| Contrave ER + Conventional Nutritional Education | Active comparator | Drug: Contrave ER Behavioral: Conventional Nutritional Education Receives: Drug: Contrave ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission
The diabetes remission rate at Week 12 will be compared between the intervention and control groups relative to baseline. Remission of type 2 diabetes is defined, in accordance with the 2021 consensus report by American and European experts (Diabetes Care 2021;44:2438-44), as an HbA1c level of less than 6.5% at the end of the 12-week intervention, following discontinuation of all glucose-lowering medications at baseline.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (1)
Body weight
Body weight will be measured in kilograms (kg) using a calibrated scale. Changes from baseline will be evaluated.
Measured: Assessments will be performed at baseline and week 12. For participants who consent to the extension of the study period, additional assessments will be conducted at weeks 18 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Jul 2025
- Primary completion27 Jan 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, Type 2Studies 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
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeouido St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HK inno.N Corporation, Handok Inc., Kwang Dong Pharmaceutical co., ltd.
- Responsible party
- Sponsor
- Investigators
- Hyuk-Sang Kwon, MD, PhD, Principal investigator, The Catholic University of Korea, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753447
- Sponsor's protocol ID
- SC25MISV0035
- Other IDs
- 2021R1A2C2013890
- Acronym
- K-Direct2
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calorie Restricted Dietary Intervention in Type 2 Diabetes Patients With Obesity for Remission
- ClinicalTrials.gov ID
- NCT07753447
- Acronym / sponsor ID
- K-Direct2 / SC25MISV0035
- Conditions
- Diabetes, Type 2, Obesity &Amp; Overweight
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Yeouido St. Mary's HospitalUniversity, hospital or other
- Collaborators
- HK inno.N Corporation, Handok Inc., Kwang Dong Pharmaceutical co., ltd.
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 7 Aug 2026 (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 study aims to induce remission of type 2 diabetes through dietary intervention for weight reduction.
Detailed description
To promote weight loss, nutritionally balanced low-calorie meal boxes (provided by CJ CheilJedang) will be used. For the purpose of setting an active control group, all participants will also receive Contrave Extended-Release tablets (provided by Kwangdong Pharmaceutical), a medication indicated for weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contrave ER + Low-calorie Meal Box + Nutritional Intervention | Experimental | Drug: Contrave ER, Combination Product: Low-calorie meal boxDrug: Contrave ER Combination Product: Low-calorie Meal Box Behavioral: Nutritional Intervention |
| Contrave ER + Conventional Nutritional Education | Active comparator | Drug: Contrave ERDrug: Contrave ER Behavioral: Conventional Nutritional Education |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged ≥19 and <60 years
- Confirmed diagnosis of type 2 diabetes
- Diagnosed with diabetes within the past 6 years
- Most recent BMI within the past 3 months ≥27 kg/m²
- Most recent HbA1c within the past 3 months <11%
Key exclusion criteria (11 listed)
- Pregnant women or those who may become pregnant during the study period
- Individuals with organ failure, such as heart failure, hepatic failure, renal failure, or chronic obstructive pulmonary disease
- History of cardiovascular disease or cancer treatment within the past 6 months
- Acute illness requiring hospitalization (e.g., infection or surgery) within the past 3 months
- Presence of endocrine disorders that may affect body weight, such as Cushing's syndrome
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 |
|---|---|---|
| Contrave ERContrave is an extended-release combination of naltrexone and bupropion, approved for chronic weight management. It acts on the central nervous system to reduce appetite and control food cravings. | Drug | Contrave ER + Conventional Nutritional Education, Contrave ER + Low-calorie Meal Box + Nutritional Intervention |
| Low-calorie meal boxThe meal boxes provided by CJ CheilJedang are nutritionally-balanced, low-calorie HMR products developed with reduced levels of sodium, sugar, and saturated fats. | Combination product | Contrave ER + Low-calorie Meal Box + Nutritional Intervention |
Primary outcome
Remission
Time frame: From enrollment to the end of treatment at 12 weeks
The diabetes remission rate at Week 12 will be compared between the intervention and control groups relative to baseline. Remission of type 2 diabetes is defined, in accordance with the 2021 consensus report by American and European experts (Diabetes Care 2021;44:2438-44), as an HbA1c level of less than 6.5% at the end of the 12-week intervention, following discontinuation of all glucose-lowering medications at baseline.
1 secondary outcome
Body weight
Time frame: Assessments will be performed at baseline and week 12. For participants who consent to the extension of the study period, additional assessments will be conducted at weeks 18 and 24.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Hyuk-Sang Kwon, MD, PhD principal investigator
The Catholic University of Korea, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Contrave ER and Low-calorie meal box in people with Diabetes, Type 2 and Obesity &Amp; Overweight, run by Yeouido St. Mary's Hospital 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 7 Aug 2026. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Remission (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.