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NCT01184560
A Randomized, Double-blind, Placebo-controlled, Investigator-initiated Study to Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine
NA trial testing Sibutramine in Obesity in 174 participants. Completed in 1 July 2010.
1 July 2010
Quick facts
| Lead sponsor | Gachon University Gil Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 174 |
| Start date | 1 February 2010 |
| Primary completion | 1 July 2010 |
| Estimated completion | 1 July 2010 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Sibutramine (SIBUTRAMINE) — full drug profile →
- Orlistat — full drug profile →
Conditions studied
- Obesity — all drugs for Obesity →
Sponsor
Gachon University Gil Medical Center
Who can join
Adults 18 to 50, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Weight
Time frame: with in 18weeks
Weight -
BMI(Body Mass Index)
Time frame: with in 18weeks
BMI(Body Mass Index) -
waist circumference
Time frame: with in 18weeks
waist circumference -
blood pressure
Time frame: with in 18weeks
blood pressure -
fat mass
Time frame: with in 18weeks
fat mass -
visceral fat mass improvement
Time frame: with in 18weeks
visceral fat mass improvement
Sponsor's own description
The purpose of this study, conducted academic Pilot research purposes, this is not clear as to permit. when orlistat to sibutramine merge if there are additional effects of BMI and group, which has an attribute that is greater for the combined effect is to analyze. * Study phase: Investigator-initiated clinical study (Pilot study) * Method of blinding: Double-blind * Control: Placebo-controlled * Assignment method: Randomization (Sibutramine monotherapy group: Orlistat and Sibutramine combination group = 1 : 1) * Studied disease: Obesity * Study population: Subjects eligible for inclusion/exclusion criteria * Dosing period: Total 18 weeks Run-in period (2 weeks), dosing period (12 weeks) and post-dosing observation period (4 weeks)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effect of the G-protein β3 subunit 825T allele on the change of body adiposity in obese female.
Hwang IC, Kim KK, Ahn HY, Suh HS, et al · · 2013 · cited 11× · PMID 23061407 · DOI 10.1111/dom.12023
Verify or expand the search:
- PubMed search for NCT01184560
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Gachon University Gil Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01184560 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gachon University Gil Medical Center
- Last refreshed: 18 August 2010
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01184560.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing