None listed
Conditions
Brief summary
The study is testing a new drug called Tinodasertib to see if it is safe and well tolerated when taken by people who are overweight or obese. The drug is being looked at as a potential treatment to help with weight management. The study will take place at one location and include 64 participants, who will be randomly assigned to one of four groups. One group will get a placebo (a pill with no active drug), the other 3 groups will get either 10mg, 20mg or 30mg of Tinodasertib once a day. Everyone will take their assigned pill daily for 12 weeks, and all participants will also get advice on healthy eating and exercise throughout the study. Before starting the treatment, there is a 3-week screening period to check if people qualify. After the 12-week treatment there is a 3 week follow/up period to monitor participants health.
Interventions
This study is a Phase 1b, single center, randomised, placebo-controlled, double-blind, parallel design study to assess the safety and tolerability of 3 doses of tinodasertib administered daily orally compared with placebo for weight management in subjects who have obesity or are overweight with at least one obesity-related comorbidity. Subjects are randomized in a 1::1::1::1 ratio into placebo and 3 different test dose arms. (10mg, 20mg and 30 mg). All subjects will receive diet and physical act
This study is a Phase 1b, single center, randomised, placebo-controlled, double-blind, parallel design study to assess the safety and tolerability of 3 doses of tinodasertib administered daily orally compared with placebo for weight management in subjects who have obesity or are overweight with at least one obesity-related comorbidity. Subjects are randomized in a 1::1::1::1 ratio into placebo and 3 different test dose arms. (10mg, 20mg and 30 mg). All subjects will receive diet and physical activity counselling using a standardized approach throughout the study. The study encompasses a 3-week screening period including a screening visit to assess eligibility, followed by a randomization visit and subsequently a 12-week treatment period concluded with a 3 week follow/up period. During screening the participant will be asked about their level of daily activity, their medical history and any concomitant medication. A full Physical examination including height and weight measurement will be done as well as a blood draw and urine sample for routine lab tests including blood for biomarker testing. The participant will complete a health questionnaire and perform a stair climbing test. The total time for screening is approximately 2 hours and will determine if the participant is suitable for the study and to continue to be enrolled. The tests may be done over several clinic visits. The test medicine will be administered orally daily at one of the three low doses and will be compared to a matching blinded placebo. The Test medicine is provided as 24 capsule bottles sufficient for 3 weeks at week 3, 6 and 9. Accountability is performed for the returned capsules during each visit in addition to weekly diary reviews.
Sponsors
Karyogen
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Obese or overweight with the presence of at least one comorbidity (treated or untreated) And a medical history of at least one self-reported unsuccessful dietary effort to lose body weight 2.. Women of childbearing women must have neg pregnancy test and agree to use contraception/abstinence or be postmenopausal. 3. Male subjects: sterilized or use contraception/abstinence
Exclusion criteria
1. Has received/taken an approved or experimental weight loss medication within the past 3 months prior to screening 2. Subject undertook any therapy intended for weight management within the past 3 months prior to screening 3. A self-reported change in body weight of more or equal 5% within the last 90 days prior to the screening visit 4. Have prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty within 1 year prior to screening 5. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening 6. Type 1 or type 2 diabetes mellitus or have at least 1 laboratory value suggestive of diabetes during screening, including 1 or more HbA1c more or equal 6.5%, fasting serum glucose higher or equal 126mg/gl, or random glucose higher or equal 200mg/dl or received treatment with glucose-lowering agent(s) within 90 days prior to screening 7. Uncontrolled thyroid disease, defined as TSH higher than 6.0mIU/l or 0.35mIU/l as measured at screening 8. Have renal impairment measures as eGFR < 30ml/min/1.73m2, calculated by the CKD-EPI equation 9. Have a known clinically significant gastric emptying abnormality (eg Severe gastroparesis, or gastric outlet obstruction) in the last 3 months prior to screening or chronically take drugs that directly affect GI motility. 10. History of major depressive disorder within 2 years or diagnosis of other severe psychiatric disorders 11. Have obesity induced by other endocrinologic disorders (eg Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (eg Melanocortin 4 receptor deficiency or Prader Will syndrome) 12. Significant systemic diseases affecting muscle function, including but not limited to - Endocrine disorders - Renal failure or significant electrolyte imbalances affecting muscle function - Chronic steroid use or other medications known to cause muscle atrophy or weakness 13. Ongoing or history of frequent intermittent or chronic tachyarrhytmia syndromes
Outcome results
None listed