Clinical Trials

Numerous clinical trials evaluate Orlistat across Phase 1 through Phase 4 for indications including obesity, overweight status, type 2 diabetes, non-alcoholic fatty liver disease, and binge eating. Sponsored by pharmaceutical organizations like GlaxoSmithKline and EMS alongside academic institutions such as Yale University and East Carolina University, these studies encompass completed, terminated, withdrawn, and actively recruiting statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07326839 NOT_YET_RECRUITING
Gout; Obesity
XueMei Guo
 2025-12-10
NCT07714070 NOT_YET_RECRUITING
Endometrial Neoplasms; Endometrial Cancer; Atypical Endometrial Hyperplasia; Progestin Resistance
Peking University People's Hospital
 2026-07 PHASE2
NCT07301437 NOT_YET_RECRUITING
Overweight and Obese Adults
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
 2026-05-01 PHASE4
NCT05816343 RECRUITING
Type 1 Hyperlipoprotenemia
University of Texas Southwestern Medical Center
 2024-01-26 PHASE2
NCT06854614 ACTIVE_NOT_RECRUITING
Obesity
The Cleveland Clinic
 2025-03-01 PHASE4
NCT07747909 RECRUITING
Polycystic Ovary Syndrome
Khyber Medical University Peshawar
 2026-01-01
NCT06993428 NOT_YET_RECRUITING
Overweight or Obese; Obesity and Overweight
Empros Pharma AB
 2025-05-20 PHASE2
NCT06818955 NOT_YET_RECRUITING
Lung Adenocarcinoma; Osimertinib
Ping Peng
 2025-02-16 PHASE2
NCT05579249 COMPLETED
Obesity
Novo Nordisk A/S
 2023-01-19 PHASE4
NCT06501326 UNKNOWN
Non-alcoholic Fatty Liver Disease; Obesity
Affiliated Hospital of Nantong University
 2023-11-01 PHASE4
NCT05496075 COMPLETED
Uric Acid
Shanghai 10th People's Hospital
 2022-08-26 PHASE4
NCT05934110 UNKNOWN
Overweight or Obesity
Empros Pharma AB
 2023-04-18 PHASE2
NCT05760677 UNKNOWN
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries; T2D
Affiliated Hospital of Nantong University
 2022-10-01 PHASE1
NCT04531176 TERMINATED
Type 2 Diabetes; Obesity
The Cleveland Clinic
 2020-09-01 PHASE4
NCT03582722 COMPLETED
Polybrominated Biphenyl Poisoning
Emory University
 2018-09-14 PHASE4
NCT04521751 COMPLETED
Overweight or Obesity
Empros Pharma AB
 2020-05-07 PHASE1; PHASE2
NCT05076474 COMPLETED
Bioequivalence
Shandong New Time Pharmaceutical Co., LTD
 2020-10-01
NCT02069197 UNKNOWN
Obesity; Diabetes; Obstructive Sleep Apnea
Mid-Atlantic Epilepsy and Sleep Center, LLC
 2014-01 PHASE2
NCT01675154 TERMINATED
Type 1 Hyperlipoproteinemia
University of Texas Southwestern Medical Center
 2015-11 PHASE2
NCT02432209 COMPLETED
Infertility, Female
Yale University
 2015-08 PHASE3
NCT03675191 COMPLETED
Obesity; Overweight
Gangnam Severance Hospital
 2018-10-16
NCT03383068 UNKNOWN
PCOS; Impaired Glucose Tolerance
RenJi Hospital
 2018-01-01 PHASE4
NCT02767531 COMPLETED
Hyperlipoproteinemia Type I; Hypertriglyceridemia
University of Texas Southwestern Medical Center
 2015-12 PHASE2
NCT01755676 COMPLETED
Obesity
EMS
 2016-09 PHASE3
NCT01755676 Completed
Obesity
EMS
 2016-09 Phase 3
NCT02141230 Withdrawn
Weight Loss
GlaxoSmithKline|Hamell
 2015-12 Not Applicable
NCT01597531 TERMINATED
Type 2 Diabetes; Gastric Banding
East Carolina University
 2012-06 PHASE4
NCT00704912 COMPLETED
Polycystic Ovary Syndrome
Milton S. Hershey Medical Center
 2008-09 PHASE2
NCT01351753 TERMINATED
Obesity; Metabolic Syndrome X
University of Iowa
 2011-03 PHASE2
NCT00829283 COMPLETED
Obesity; Binge Eating
Yale University
 2008-11
NCT00152360 COMPLETED
Obesity; Heart Diseases
University of British Columbia
 2005-06 PHASE4
NCT01719419 WITHDRAWN
Overweight
Pennington Biomedical Research Center
 2012-03
NCT01797757 COMPLETED
Obesity
Société des Produits Nestlé (SPN)
 2012-01
NCT01320228 COMPLETED
Obesity
University of Copenhagen
 2011-04
NCT01719419 Withdrawn
Overweight
Pennington Biomedical Research Center
 2012-03 Not Applicable
NCT00001723 COMPLETED
Diabetes Mellitus; Hypertension; Metabolic Disease; Obesity; Sleep Apnea Syndrome
Jack Yanovski
 1998-05 PHASE2
NCT00871845 TERMINATED
Obesity; Insulin Resistance; Metabolic Syndrome; Hepatitis C
Hossam Kandil
 2008-09
NCT01035333 COMPLETED
Obesity
Albany College of Pharmacy and Health Sciences
 2009-11 PHASE4
NCT01126970 COMPLETED
Obesity
Shionogi
 2010-04 PHASE2
NCT00516919 COMPLETED
Obesity; Binge Eating
Yale University
 2007-08 PHASE4
NCT01047657 COMPLETED
Asthma; Obesity; Weight Loss
University of Sao Paulo General Hospital
 2009-11 PHASE3
NCT00940628 COMPLETED
Obesity
Hoffmann-La Roche
 2008-04 PHASE3
NCT01184560 COMPLETED
Obesity
Gachon University Gil Medical Center
 2010-02
NCT02529631 COMPLETED
Overweight; Obesity
Certmedica International GmbH
 2009-11
NCT00794963 TERMINATED
Metabolic Syndrome
Northwell Health
 2008-11
NCT01170806 COMPLETED
Obesity
University of Campinas, Brazil
 2009-10
NCT01414465 COMPLETED
Overweight
University of Campinas, Brazil
 2009-10
NCT01332448 Completed
Obesity
GlaxoSmithKline
 2010-02 --
NCT01475019 UNKNOWN
Obesity; Polycystic Ovaries Syndrome
Aristotle University Of Thessaloniki
 2004-01 PHASE4
NCT01414465 Completed
Overweight
University of Campinas Brazil|Germed Pharma
 2009-10 Not Applicable
NCT01003483 COMPLETED
Obesity
Yazd Research & Clinical Center for Infertility
 2008-12-01 PHASE2
NCT00752726 COMPLETED
Obesity; Overweight
GlaxoSmithKline
 2008-09 PHASE4
NCT01550926 COMPLETED
Overweight
GlaxoSmithKline
 2009-02 PHASE1
NCT02706067 COMPLETED
Obesity
Hoffmann-La Roche
 2002-07 PHASE4
NCT00601354 COMPLETED
Overweight; Eating Disorders
Stanford University
 2007-09
NCT00292799 COMPLETED
Anovulation; Obesity
Sheffield Teaching Hospitals NHS Foundation Trust
 2006-02
NCT00108524 COMPLETED
Diabetes Mellitus; Obesity
US Department of Veterans Affairs
 2004-07
NCT00115063 TERMINATED
Obesity
Pennington Biomedical Research Center
 2005-07 PHASE4
NCT00422058 COMPLETED
Metabolism and Nutrition Disorder; Obesity
Novo Nordisk A/S
 2007-01-10 PHASE2
NCT00533481 COMPLETED
Obesity
Merck Sharp & Dohme LLC
 2004-02 PHASE2
NCT00160407 COMPLETED
Fatty Liver; Hepatitis
St. Louis University
 2003-10 PHASE4
NCT00461799 COMPLETED
Crigler-Najjar Syndrome
University Medical Center Groningen
 2003-09
NCT00212199 COMPLETED
1. Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2002-01 PHASE4
NCT00156897 COMPLETED
Non-Insulin-Dependent Diabetes Mellitus; Obesity
Alizyme
 2004-12 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-01-08)

Check the Orlistat product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Orlistat acts as a lipase inhibitor that targets human gastric and pancreatic lipases, blocking the enzymatic hydrolysis of dietary triglycerides into absorbable free fatty acids and monoglycerides. By preventing the gastrointestinal absorption of dietary fats and reducing caloric uptake, this biochemical inhibition reduces cellular lipid accumulation, directly underpinning its therapeutic evaluation in clinical trials for obesity, type 2 diabetes, and non-alcoholic fatty liver disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.