Obesity
Conditions
Interventions
Product Name: TM30338
Pharmaceutical Form: Solution for injection
INN or Proposed INN: obinepitide
CAS Number: 348119-84-6
Current Sponsor code: TM30338
Other descriptive name: Human Pancreatic Peptid
Sponsors
7TM Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) BMI between 30 to 40 kg/m2 inclusive and obese b) Either male or female c) Age 18 to 60 years inclusive d) Stable lifestyle as defined by consistent smoking, exercise, and eating patterns for at least 6 months prior to screening and willingness to maintain these patterns for the course of the study e) Stable weight over past 2 months i.e. a change in body weight =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Use of any anorexigenic agent or food supplement, including but not limited to phentermine, fenfluramine, hypericum, phenylpropanolamine, orlistat, sibutramine and rimonabant/Acomplia b) Use of any systemic or topical prescription medication within 7 days of the first administration of study drug with the exception of hormonal contraceptives, diuretics for hypertension, calcium antagonists, ACE inhibitors, ARB therapy, statins, progesterone, estrogen, levothyroxine, inhaled steroids, inhaled bronchodilators, topical medications with no significant systemic effect, and/or the occasional use of NSAIDS and/or antihistamines. NOTE: see Prior and Concomitant Therapy (10.5) for further restrictions. c) Use of any systemic or topical non-prescription medication within 3 days of the first administration of study drug with the exception of vitamin/mineral supplements, topical medications with no significant systemic effect, and/or the occasional use of NSAIDS, acetaminophen, antihistamines, and/or other medication that, in the opinion of the Investigator, will not interfere with the study procedures or compromise the subjects safety. NOTE: see Prior and Concomitant Therapy (10.5) for further restrictions. d) History of any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular (other than well-controlled hypertension or hyper/dyslipidaemia), respiratory (other than well-controlled asthma), metabolic, endocrine (other than well-controlled hypothyroidism), haematological, gall bladder or other major disorders e) History of major DSM-IV psychiatric disorder including, but not limited to substance-related disorders, schizophrenia and other psychotic disorders, mood disorders (e.g. major depression, bipolar disorder), and anxiety disorders f) History of eating disorders (e.g. bulimia, anorexia nervosa) or is regularly engaged in binge-eating or purging behaviour (i.e. self-induced vomiting or the misuse of laxatives, diuretics, or enemas) g) Any psychological eating problems indicated at Screening in the 3-factor eating questionnaire [2]. h) Liver function test values > 1.5 fold the upper normal limit i) Triglycerides > 6.8 mmol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the change in body weight after 28 days of consecutive dosing with TM30338 in obese subjects;Secondary Objective: To determine the safety and tolerability of TM30338 during 28 days of consecutive dosing in obese subjects;Primary end point(s): | — |
Countries
Sweden
Outcome results
None listed