Obesity & Overweight / Diabetes, Type 2 / Low-calorie meal box · Phase 4 Trial

Calorie Restricted Dietary Intervention in Type 2 Diabetes Patients With Obesity for Remission

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed Phase 4 trial registration for a 12-week calorie-restricted dietary intervention combined with Contrave ER in 25 obese patients with type 2 diabetes, aimed at remission. Results have not been reported in this registry record as of the posting date.

What was studied

Phase 4, Interventional, Randomized, Parallel, Open label, Treatment purpose. Diabetes, Type 2, Obesity &Amp; Overweight; age from 19 Years; to 60 Years. Intervention: Contrave ER + Low-calorie Meal Box + Nutritional Interventi…. Compared with: Contrave ER + Conventional Nutritional Education — Active Comparator. n = 25. 1 site: South Korea.

Key findings

Safety

Results are not reported in this registry record; efficacy, safety, and remission rates are unknown

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a completed Phase 4 interventional study with small sample size (n=25) and surrogate endpoint (remission status at 12 weeks); results are not yet reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Remission (assessed at From enrollment to the end of treatment at 12 weeks)

DesignPhase 4, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationDiabetes, Type 2, Obesity &Amp; Overweight; age from 19 Years; to 60 Years

Sample size25

InterventionContrave ER + Low-calorie Meal Box + Nutritional Interventi…

ComparatorContrave ER + Conventional Nutritional Education — Active Comparator

Setting1 site: South Korea

Reported figures

Quoted from the source exactly as published.

Sample size25

Primary outcomeRemission of type 2 diabetes at 12 weeks

Study phasePhase 4

Follow-up duration12 weeks

Caveats

Results are not reported in this registry record; efficacy, safety, and remission rates are unknown
Small sample size limits generalizability and precision of any future results
Single-arm design; no control or comparator group described
Study design details such as blinding, allocation method, and statistical analysis plan are not provided in this registry entry

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 4 interventional design; single-arm with two active components

Directness

strong

Primary outcome is remission of type 2 diabetes, clinically relevant endpoint

Consistency

insufficient

Registry record only; no results reported, cannot assess consistency

Risk of bias

insufficient

Registry record does not describe allocation concealment, blinding, or follow-up methods

Sample adequacy

limited

Only 25 participants enrolled; very small sample for evaluating remission

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07753447). This is a study registration, not published results. Lead sponsor: Yeouido St. Mary's Hospital. Recruitment status: COMPLETED. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 25 participants (ACTUAL). Conditions: Diabetes, Type 2, Obesity & Overweight. Interventions: DRUG: Contrave ER; COMBINATION_PRODUCT: Low-calorie meal box. Primary outcome measures: Remission , From enrollment to the end of treatment at 12 weeks. Brief summary: This study aims to induce remission of type 2 diabetes through dietary intervention for weight reduction.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Yeouido St. Mary's HospitalObesity & OverweightDiabetes, Type 2Low-calorie meal boxContrave ERNCT07753447