Obesity with Type 2 Diabetes Self-scheduler

Basic Criteria:  

• Age 18+  

• BMI ≥27 kg/m² 

• Must have type 2 Diabetes with A1C ≥7% and ≤ 11%. 

• • If taking meds must be stable for at least 3 months prior to Screening.  

• • Can be treated with diet/exercise alone or any oral glycemic-lowering agent EXCEPT for amylin analogues or dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1R agonists or dual GLP-1/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists. 
  • Please see list of exclusionary meds here 
  • Glucose readings (SMBG) of >270 on CONSECUTIVE days is OK for screening.  Readings of >270 on non-consecutive days is exclusionary 
  • Must be willing to commit to weekly visits for the first 8 months of the study

Answers Must be NO 

• Are you willing to commit to weekly visits for the first 8 months of the study?
• If female of childbearing potential, are you currently pregnant, breastfeeding, or planning to become pregnant?   

• Do you have Type 1 diabetes, a history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except Type 2 diabetes? 

•  Have you had 1 or more episodes of severe hypoglycemia and/or 1 or more episodes of hypoglycemia unawareness in the past 6 months? 

• Have you participated in a previous clinical trial in which VK2735 was the investigational product? 

• Have you lost or gained more than 11 lbs. (>5%) of body weight in the past 90 days? 

• Do you have proliferative diabetic retinopathy, diabetic macular edema or non-proliferative diabetic retinopathy that requires acute treatment? 

• Do you have 2 or more confirmed fasting self-monitoring blood glucose (SMBG) values > 270 mg/dL (on 2 non-consecutive days) within the past 4 weeks? 

• Have you had or are you planning to have surgical treatment for obesity? Exception: Liposuction or Abdominoplasty performed at least one year ago are allowed. 

• Have you ever had or planned to have endoscopic and/or device-based therapy for obesity? 

• Have you had a weight loss device implanted or removed in the last 6 months (such as a mucosa ablation, gastric artery embolization, intragastric balloon, or duodenal-jejunal endoluminal line)?  

• Have you ever abused/misused Drug/alcohol? Stable use of medical/therapeutic cannabis or cannabidiol products is allowed during the trial. 

• Do you have a history of Pancreatitis?  

• Have you been admitted to a psychiatric hospital in the past 12 months? 

• Have you attempted suicide in the past 5 years? 

• Do you have uncontrolled blood pressure of ≥ 160/100 mmHg? Must be stable on Blood pressure meds for at least 30 days. 

• Do you have any blood disorders that may interfere with HbA1c measurement (for example, Hemolytic anemias, sickle cell disease) 

• Do you have an unstable Thyroid disease? Patients with history of thyroidectomy or hypothyroidism may be included, if hormone replacement dose has been stable for 3 months. 

• Have you used Adderall and any products containing amphetamine and/or dextroamphetamine in the 12weeks (3months)? 

• Do you have a history of Cancer in the last 5 years? Exception: Basal/squamous Cell Skin Carcinomas, In Situ (Cervix or Prostate) Cancer are allowed  

• Have you had any of the following conditions in the last 3 months? Heart Attack, Stroke, TIA, Coronary or Carotid Revascularization Procedure, Hospitalization for Heart Failure, unstable angina.  

• Do you have NYHA class IV heart failure? (Symptoms for heart failure even at rest) 

• Do you have chronic kidney disease with eGFR <30 (stage 4 or 5)? 

• Are you currently receiving or used within the past 3 months any chronic systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intraarticular, or inhaled preparations)? 

• Do you have a significant active autoimmune abnormality (E.g. lupus or rheumatoid arthritis) that has required the use of glucocorticoids in the past 3months? 

• Have you had major surgery in the last 3 months or have any planned upcoming surgery during study participation?  

• Have you ever had an organ transplant? Corneal transplants are allowed  

• Have you had Symptomatic Gallbladder Disease in the last 2 years? Gallbladder removed at least 3 months ago with no complications allowed.  

• Do you have a significant gastric emptying abnormality like gastroparesis or chronically taking drugs that are used to treat disorders of gastrointestinal motility? 

• Do you have uncontrolled intermittent or chronic tachyarrhythmia syndromes like atrial fibrillation (AFIB), supraventricular tachycardia (SVT), positional orthostatic tachycardia syndrome (POTs)? Exceptions: 

• • History of chronic AFIB treated with medication and on stable doses for at least 3 months. A single episode with no recurrence and did not require treatment they can screen. 

• • History of premature atrial contractions or premature ventricular contractions  

• Do you have HIV, Hepatitis B, or Hepatitis C, other acute or chronic hepatitis, cirrhosis, NASH/MASH? NAFLD/MASLD is allowed. 

• Have you donated blood or blood products of ≥500 mL in the past 8 weeks, had blood transfusion/severe blood loss in the past 3 months, or have a known blood disease? 

• Is your obesity caused by endocrine disorders or monogenetic mutation like Cushing’s syndrome, Melanocortin 4 Receptor deficiency or Prader Wili Syndrome? 

• Do you have a personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia Type 2 (MEN2)?  

• Have you received any investigational drug or product, or participated in an investigational drug study in the past 2 months? 

• Do you have any other condition, surgery, or take concomitant medication that would make participation in this study inappropriate or interfere with the trial evaluation, procedure or completion? 

Answers Must be YES 

• If applicable, have you been stable on your psychiatric meds for at least 8 weeks? 

• If applicable, have you been stable on cholesterol meds for at least 30 days? 

• If female and of childbearing potential, do you agree to use double contraception with condom and an acceptable, highly effective contraception from Screening until at least 90 days after the last dose of study drug? 

• • Established hormonal contraception (with approved oral contraceptive pills, long-acting implantable hormones, injectable hormones which must be stable for at least 4 weeks) 

• • Vaginal ring, IUD or IUS 

• • Documented evidence of bilateral tubal occlusion or bilateral tubal ligation at least 6 months prior to Screening 

• • Vasectomy for male partner provided the male partner is a sole partner 

• • Complete abstinence for the duration of the study and for 3 months after the last study treatment. Same sex partner is considered abstinence. 

• If female, and not of childbearing potential, do you meet one of the following? 

• • Hysterectomy, bilateral salpingectomy, bilateral oophorectomy 

• • Postmenopausal defined as ≥55 years old, not on hormone therapy and no cycle at least 12 months without alternative cause 

• • At least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy 

• • > 40 and < 55 years of age with an intact uterus, not on hormone therapy and with no menses for at least 1 year without an alternative medical cause 

• If male, do you agree to use contraception during the treatment period and for at least 90 days after the last dose of study drug and refrain from donating sperm during this period? 

• • Complete abstinence, documented vasectomy (≥30days), same sex partner 

• • Use barrier contraception and female partner must use a second effective birth control (listed above) during the study and for at least 90 days after the last dose 

• Are you willing to refrain from donating blood or blood products while participating in this study?
• Are you willing to refrain from caffeine, tobacco, medically indicated marijuana or cannabidiol products, and strenuous exercise at least 24 hours prior to each clinic visit? 

Compensation may be available for time and travel

Insurance is not required 

PLEASE NOTE: Please confirm your eligibility before your appointment by calling 210-714-0067 

If you do not see an available appointment, please call 210-714-0067 for availability 

Transportation may be available. Call 210-714-0067