Stipend and Dates
Up to $15,300. (Multiple payments)
|Note: You cannot pick which cohort you go into. The 1st cohort is filled before patients are placed in the next cohort. You must be able to do any of the cohorts. *If you dosed for Part A of this study you cannot participate in Part B.||Cohort 1B|
|Day -17 - This is the LAST day to screen childbearing females or females with tubal ligations. These females CANNOT screen after this date.||Oct 01 (We are no longer taking childbearing or females with tubals for this cohort)|
|Only males and Non-childbearing women can screen after Oct 01. (PMP, Hysterectomy, salpingectomy or oophorectomy)|
|Day -2 Admit||Oct 17, 2022 Mon|
|* Holter monitoring starts on Day -1 to Day 13 (No electronics = cell phones, computers, TV ) *1st payment within 10 business days after completing Day 7.|
|Day 13 Discharge (a payment within 10 business days after this day is completed)||Oct 31, 2022 Mon|
|Day 15 Outpatient visit||Nov 02 Wed|
|Day 17 Outpatient visit||Nov 04 Fri|
|Day 20 Outpatient visit||Nov 07 Mon|
|Day 24 Outpatient visit||Nov 11 Fri|
|Day 31 Outpatient visit (a payment within 10 business days after this day is completed)||Nov 18 Fri|
Or call 210-225-5437 for more information
Healthy non-smoking overweight Males and Females
BMI: 25.0 to 34.9 kg/m2
Indication: The investigational drug is being developed as a potential treatment for overweight and/ obesity.
Route of Administration: Oral
Washout from previous study: Participation in any clinical study within 30 days before receiving study drug in this study.
Acceptable Birth Control for Females (if Childbearing): Females of child bearing potential must agree to use a highly effective method of contraception during the study treatment period and until 19 days after the end of the study. Highly effective methods of contraception are listed below:
- Intrauterine device with male condoms
- Intrauterine system with male condoms
- Partner has had a Vasectomy (confirmed by the absence of sperm)
- Stable Hormonal contraception with approved oral, intravaginal, transdermal, injectable or implantable (and male condoms).
- Bilateral tubal occlusion/ligation
- Sexual Abstinence
Females in the following categories are considered non-childbearing:
- Documented total hysterectomy (removal of uterus), bilateral salpingectomy (removal of both Fallopian tubes), or bilateral oophorectomy (removal of both ovaries)
- Menopause more than 12 months prior to study entry (stopped having monthly menstrual periods more than 12 months ago).
- Greater than or equal to 60 years of age
The male participant should use a condom during study treatment and until the end of study.
- 8 hours fasting is required for lab work (only water is allowed)
- If taking medications, bring them to your screening appointment (including prescription, over the counter, herbal supplements and vitamins)
- Bring a valid, non-expired photo ID with you when you attend your screening visit. We accept a valid government issued identification card such as a driver's license, state issued ID card or passport. You will be required to show this same photo ID at all study visits
- Arrive 30 minutes before your appointment to complete paper work.
- NO 0009-0625 Part B
- Healthy Overweight Males and Females
- Not Currently Screening.
- Male or Female
- Payment amount
- Up to $15,300
- 18 - 55