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An open-label study to compare the efficacy and safety of Liraglutide versus naltrexone Hcl/bupropion in obese patients

An open-label study to compare the efficacy and safety of Liraglutide versus naltrexone Hcl/bupropion in obese patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004908
Enrollment
40
Registered
2020-04-10
Start date
2020-01-16
Completion date
Unknown
Last updated
2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Adult obese patients who are not well-controlled are assigned to Saksenda and Contrab counties according to their respective indications after outpatient treatment. Saxenda group is 0.6 mg/day

Sponsors

Kyung Hee University Hosipital at Gangdong
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. BMI 30 kg/m2 or higher 2. BMI 27 kg/m2 + metabolic diseases (hypertension, hyperlipidemia, pre-diabetes stages) 3. Those who have never used Liraglutide or naltrexone Hcl/buproposition Hcl 4. The person who voluntarily agreed to participate in this clinical trial

Exclusion criteria

Exclusion criteria: 1. If you have a liver disease of a specific cause, such as viral hepatitis, autoimmune hepatitis, alcoholic liver disease 2. Drug users who can affect the weight, fatty liver, and gut microflora 3. People with mental illness 4. Pregnant and lactating women 5. Those who are on dialysis due to terminal renal failure 6. Beneficiaries of organ transplants, including the liver 7. Those who are being treated for hyperthyroidism or have a TSH of 10 or higher 8. People with type 1 or type 2 diabetes 9. Excluding the following laboratory test results, which may affect the performance of the test.   -> estimated GFR <30 ml / min / 1.73 m2 10. A person who has undergone surgery to modify the structure of the intestine 11. Others who are judged to be impossible to participate 12. Drinking more than one bottle of soju per week A person who has received a clinical trial drug within the last 2 months In addition, those judged to be impossible to participate

Design outcomes

Primary

MeasureTime frame
Weight change after 4/12 weeks of treatment compared to baseline;Changes in body fat through BIA(Bio electrical Impedance Analysis) after 4/12 weeks of treatment compared to baseline;Changes in visceral fat area, subcutaneous fat area, and visceral / subcutaneous fat area ratio through fat CT 12 weeks after treatment compared to baseline

Secondary

MeasureTime frame
Percentage of patients losing 5% or more weight;Waist circumference, hip circumference, waist / hip circumference, body mass index (BMI);Changes in liver / spleen ratio measured on Fat CT;Changes in blood lipid (Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride) and liver battery;Fasting glucose, fasting insulin, C-peptide, HOMA-IR(homeostasis model assessment for insulin resistance), HOMA-ß(homeostasis model assessment - ß);High sensitivity C reactive protein(hs-CRP), leptin, adiponectin, Tumor necrosis factor (TNF-a), Interleukin 9(IL-6), HbA1C changes

Countries

Korea, Republic of

Contacts

Public Contactjunghwa lee

Kyung Hee University Hosipital at Gangdong

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026