Weight reduction MedDRA version: 17.1 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Hanmi Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 18 and 1 year prior to the screening visit), the site will make an effort to retrieve medical records to document sterility. However, the absence of records will not exclude the subject. In the event that medical records cannot be obtained, serum and urine pregnancy testing will be conducted. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels = 40 IU/mL at screening. A highly effective method of birth control is considered to be 1 of the following: a) An oral or implanted hormonal method of contraception (if it has been used for = 3 months prior to study drug administration) while also using a barrier method (i.e., a condom or a diaphragm); b) A hormone or copper intrauterine device if it has been in place for = 3 months prior to study drug administration (subjects using a nonhormonal or copper intrauterine device should also use a barrier method [i.e., a condom or a diaphragm]); c) A vasectomised partner; d) Total abstinence is acceptable; however, the subject must use a highly effective method of contraception if the subject subsequently decides not to abstain. 8. Male subjects whose partners are female of child-bearing potential must be surgically sterilized (e.g., vasectomy) for at least 3 months prior to screening or agree to practice reliable birth control methods (condom and spermicide) during the conduct of the study and for at least 3 months after the last dose of study medication. 9. Ability and willingness to comply with all protocol procedures (e.g., correct handling of investigational product, compliance with visit schedule and dietary advice, and complete trial related questionnaires) 10. Written informed consent must be obtained before any study related assessment is performed. Are the trial subjects under 18? no Number of subjects for this
Exclusion criteria
Exclusion criteria: 1. Prior participation in any study of HM11260C. 2. Pregnant or nursing (lactating) women 3. BMI > 42 kg/m² 4. Drug induced obesity 5. Diabetes mellitus (type 1, 2, or other) 6. HbA1c > 6.5% 7. Previous surgical treatment for obesity (e.g., gastric bypass, ileal bypass, gastric banding) or anticipation of surgery during the study period that may interfere with completion or compliance with the protocol, or planned elective hospitalizations 8. Any known history of severe GI disease or intolerance, gastric emptying abnormality, or inflammatory bowel disease 9. Any previous GI bleeding or ulceration related to the use of non steroidal anti inflammatory drugs (NSAIDs) within 3 months before screening 10. Known history of acute or chronic pancreatitis with presence of raised serum amylase and lipase (> 3 times the upper limit of normal [ULN]) at screening 11. History of suicide attempts or recent history (within 2 years prior to screening) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), antipsychotics, and lithium. 12. Uncontrolled hypertension, defined as resting blood pressure (BP) > 150/90 mmHg at screening. If elevated, BP will be re-checked on a separate day within the screening period. If elevated on re check, subjects may be rescreened only after being on a stable antihypertensive therapy for 3 months. . 13. Has clinically significant abnormalities on 12 lead ECG, as determined by the Investigator 14. History of invasive cardiovascular surgical procedure within 6 months of screening; or severe heart or circulatory disease, within 6 months prior to screening 15. Personal or known family history of medullary thyroid carcinoma (MTC) or a genetic condition that predisposes to MTC 16. Abnormal thyroid stimulating hormone (TSH) laboratory value > 1.5 x ULN (ULN 5 mIU/L) value or abnormal TSH value lower than the normal value ( 400 mg/dL. 18. LDL C > 160 mg/dL. 19. Liver disease, hepatitis, or clinically significant abnormal hepatic parameters suggestive of hepatic impairment (e.g., alanine aminotransferase [ALT] or aspartate aminotransferase (AST) levels > 2.5 x ULN, or total bilirubin >1.5 x ULN unless the subject has a known history of Gilbert’s syndrome) 20. Estimated glomerular filtration rate (eGFR) 60 mL/min/1.73 m2 and 30 mg/g. The eGFR will be based on the Cockcroft Gault formula at screening. Subject must not have a prior diagnosis of chronic kidney disease 21. Calcitonin levels > 20 pg/mL at screening 22. History of or positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) type 1 or 2 antibody 23. Use of cannabis (recreational or therapeutic) or a positive screen for drugs of abuse, barbiturates, or benzodiazepines that may potentially jeopardize a subject’s study compliance. Subjects who have been prescribed benzodiazepines, or low dose opiates for chronic conditions, may qualify for the study at the discretion of the investigator 24. A history of alcohol or drug abuse or drug addiction in the previous 12 months. Subjects should limit alcohol use to 14 units per week for women or 21
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the effect of HM11260C, in combination with a hypocaloric diet, on body weight over the 20 weeks from baseline in obese subjects;Secondary Objective: • To assess the safety, tolerability, and immunogenicity of HM11260C, in combination with a hypocaloric diet, over the 20 weeks from baseline in obese subjects • To assess the effect of HM11260C, in combination with a hypocaloric diet, on the metabolic profile, i.e., glucose parameters and lipid profile, of obese subjects over the 20 weeks from baseline. o Glucose parameters: fasting plasma glucose (FPG), fasting insulin, HbA1c, c peptide o Lipid profile: total cholesterol (TC), low density lipoprotein cholesterol (LDL C), high density lipoprotein cholesterol (HDL C), very low density lipoprotein cholesterol (VLDL C), and triglycerides (TG);Primary end point(s): The primary variable is the body weight (to the nearest 0.1 kg [3.5 oz]), collected from subjects at baseline, Days 1, 8, 15, 22, 36, 50, 78, 106, and 141 during the treatment period. The change in body weight from baseline to Week 21 (Day 141) and the number and the proportion of subjects who lose at least 5% of baseline body weight at Week 21 (Day 141) will be used to demonstrate the efficacy of each of the 4 doses of HM11260C versus placebo on fasting body weight reduction. ;Timepoint(s) of evaluation of this end point: The primary variable is the body weight (to the nearest 0.1 kg [3.5 oz]), collected from subjects at baseline, Days 1, 8, 15, 22, 36, 50, 78, 106, and 141 during the treatment period. The change in body weight from baseline to Week 21 (Day 141) and the number and the proportion of subjects who lose at least 5% of baseline body weight at Week 21 (Day 141) will be used to demonstrate the efficacy of each of the 4 doses of HM11260C versus placebo on fasting body weight reduction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Glucose Metabolism Parameters (FPG, fasting insulin, HbA1c, c peptide, and glucagon) - Serum Lipid Profile;Timepoint(s) of evaluation of this end point: Change from baseline | — |
Countries
Germany, Hungary, Korea, Republic of, Netherlands, United States
Contacts
Public ContactClinical director’s office
Hanmi Pharmaceutical Co., Ltd.
Outcome results
None listed