A single center, controlled, multiple dose, randomized study during two weeks, investigating the effect of the test formulation on efficacy, safety and markers for appetite regulation, glucose and lipid absorption and metabolism and body composition, in comparision with Xenical

Study Identifier:
EP-001
CT.gov Identifier:
NCT06257693
EudraCT Identifier:
2016-001055-50
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

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Study Summary

To compare the appetite/tolerability score of the test formulation (EMP16-01 90/30) with the reference formulation (Xenical).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    II
    Sex
    Male
    Age
    24 - 60 Years
    Study Drug
  • Drug: Subjects randomized to receive test formulation (EMP16-01 90/30) capsule and Xenical capsule.
    • Read More
  • Drug: Participants took theMR-OA fixed-dose combination formulation 3 times a day together with a major meal. Three different doses of MR-OAwere evaluated—60/20, 90/30, and 120/40 (mg orlistat/mg acarbose)—as well as 1 reference group who received the conventional orlistat, Xenical, with 120 mg of orlistat
  • Drug: The clinical trial consisted of 5 visits to the clinic, including screening and follow-up.5 The total duration of the experiments was 2 weeks for each subject with no overnight stays. Visit 1 included screening and a health investigation and occurred 1 to 5 weeks before the study start. On days –1 through –3, baseline questionnaires were completed by each subject outside the clinic. On study days 1 and 14 (visits 2 and 4), the drug product was administered at the research clinic together with standardized meals (breakfast and lunch) at specific times. For the remaining days, the drug product was self-administered three times a day by each subject, together with all 3 daily main meals. There were no dietary restrictions during the study days at home except that subjects had to abstain from alcohol for 24 hours and from food and drink for at least 8 hours before visits 1, 2, and 4. On day 21 (visit 5), a final follow-up visit was performed at the clinic. Visit 3, day 7 of the experimental period included a safety check-up in which plasma/serum concentrations of liver enzymes were assessed. At visit 5, about 1 week (4-10 days) after end of the experimental period, another safety follow-up was performed.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    Inclusion criteria
    • - Male subjects age > or = 24years, < or = 60 years inclusive.
    • - BMI 33 – 40 kg/m^2 or BMI 30-32 kg/m^2 together with waist circumference above 102 cm
    • - Acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
    • - Adequate renal function: Creatinine < 1.5 times upper limit of normal.
    • - Adequate hepatic function: ASAT, ALAT, ALP and GGT < 2.5 times upper limit of normal and bilirubin <1.5 times upper limit of normal.
    • - Adequate glucose control (previous not been diagnosed with diabetes Type II)
    • - Willing and able to give written informed consent for participation in the study
    Exclusion criteria
    • - History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.
    • - Any significant medical/surgical procedure or trauma within four weeks of the first administration of IMP, at the discretion of the Investigator.
    • - Any planned major surgery within the duration of the study.
    • - High blood pressure (Above 155/95 mmHg)
    • - No medication with drugs affected by or that affect orlistat and acarbose are allowed 2 weeks before the administration of the IMP
    • - Known hypersensitivity to any of the test substances.
    • - Gastrointestinal problems / diseases, e.g. inflammatory bowel diseases and Irritable bowel syndrome
    • - Cholestasis
    • - Previous bariatic surgery
    • - Previous gallbladder surgery
    • - Previous gastrointestinal surgey that might influence gastrointestinal function significantly..
    • - Chronical malabsorptionsyndrom
    • - Vitamin B12 deficiecy or other signs of achlorhydria
    • - Clinically significant abnormal laboratory values
    • - History of severe allergic, cardiac, or hepatic disease
    • - A personal or family history of Medullary Thyroid Carcinoma (MTC)
    • - A personal or family history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
    • - Shift work within 3 weeks before visit 2.
    • - Excessive intake of alcohol, as judged by the Investigator
    • - Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse.
    • - Positive screen for drugs of abuse at screening or on admission to the unit or.
    • - Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
    • - Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
    • - Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within three months of the first administration of IMP in this study. Subjects consented and screened but not dosed in previous studies are not excluded.
    • - Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
    • - Engaged in high volume physical exercise, as defined as regular high intensity physical activity (defined as greater than 70% of the maximal pulse rate for 30 min or more) with a total weekly duration of more than 120 min/week.
    • - Bile acid malabsorption

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Status
    Recruiting
    Condition(s) Treated at Site
    Prostate