NO 0009-0625 Part C and D

Stipend and Dates

Up to $26,000. (Multiple payments)

*If you dosed for Part A or B, you CANNOT do Part C or Part D. If you screened and disqualified for Part A or B, you CANNOT RESCREEN for Part C or D.

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 listed.

Day -17 -LAST day we can screen childbearing females or females with tubal ligations is (see date posted to the right)

Part C Cohort 1C = Feb 13

Study Dates -	Part C Cohort 1C
Day -2 Admit	Mar 01, 2023
Day 4 Discharge	Mar 06
Day 8 Outpatient visit	Mar 10
Day 13 Admit	Mar 15
Day 17 Discharge	Mar 19
Day 22 Outpatient visit	Mar 24
Day 27 Admit	Mar 29
Day 31 Discharge	Apr 02
Day 36 Outpatient visit	Apr 07
Day 43 Outpatient visit	Apr 14
Day 48 Admit	Apr 19
Day 52 Discharge	Apr 23
Day 57 Outpatient visit	Apr 28
Day 64 Outpatient visit	May 05
Day 69 Admit	May 10
Day 73 Discharge	May 14
Day 78 Outpatient visit	May 18
Day 82 Admit	May 23
Day 87 Discharge	May 28
Day 89 Outpatient visit	May 30
Day 91 Outpatient visit	Jun 01
Day 94 Outpatient visit	Jun 04
Day 98 Outpatient visit	Jun 08
Day 105 Outpatient visit	Jun 15

 

Click here to make an appointment for NO 0009-0625 Part C and D

Or call 210-225-5437 for more information

 

Study Criteria

Healthy non-smoking overweight Males and Females

Age:  18-55

BMI:  27.0 to 39.9 kg/m2

 

Study Information

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.

 

Study Reminders

• 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.