A Phase 4 interventional study of Contrave ER and Low-calorie meal box in Diabetes, Type 2 and Obesity &Amp; Overweight, sponsored by Yeouido St. Mary's Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Yeouido St. Mary's Hospital · Phase 4, Interventional, and Treatment
This study aims to induce remission of type 2 diabetes through dietary intervention for weight reduction.
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.
Exclusion Criteria:
Drug: Contrave ER Combination Product: Low-calorie Meal Box Behavioral: Nutritional Intervention
Drug: Contrave ER · Combination Product: Low-calorie meal box
Drug: Contrave ER Behavioral: Conventional Nutritional Education
Drug: Contrave ER
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.
The meal boxes provided by CJ CheilJedang are nutritionally-balanced, low-calorie HMR products developed with reduced levels of sodium, sugar, and saturated fats.
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.
Time frame: From enrollment to the end of treatment at 12 weeks
Body weight
Body weight will be measured in kilograms (kg) using a calibrated scale. Changes from baseline will be evaluated.
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.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Yeouido St. Mary's Hospital