Weight Loss and Type 2 Diabetes Self-Scheduler

Basic Criteria

1. Are you 18 years of age or older?
2. Have you tried to lose weight through diet changes before, without lasting success?
3. Is your BMI (body mass index) 27 or higher?
4. Have you been diagnosed with type 2 diabetes, with an A1C between 6.5% and 10.5%?
5. Are you currently managing your type 2 diabetes with either (a) diet and exercise alone, or (b) up to 3 oral (pill) diabetes medications, for at least the last 3 months?Accepted diabetes medications:
   1. Empagliflozin (Jardiance)
   2. Metformin
   3. Dapagliflozin (Farxiga)
   4. Canagliflozin (Invokana)
   5. Ertugliflozin (Steglatro)
   6. Bexagliflozin (Brenzavvy)
   7. Glipizide (Glucotrol)
   8. Glimepiride (Amaryl)
   9. Glyburide (Diabeta, Glynase)
   10. Gliclazide
   11. Pioglitazone (Actos)
   12. Rosiglitazone (Avandia)
   13. Repaglinide (Prandin)
   14. Nateglinide (Starlix)
       (NOTE: Please see prohibited meds list for more info on other meds & their washout periods)
6. Would you be willing and able to attend study visits and follow study instructions for about 18 months?

Answers Must Be NO

1. If female: Are you currently pregnant, breastfeeding, or planning to become pregnant during the study?
2. Have you ever had (or are you planning) weight-loss surgery, or a weight-loss device or procedure such as a gastric band, balloon, or similar? (Cosmetic procedures like liposuction more than 1 year ago are okay. A weight-loss device is okay if it was removed more than 6 months ago.)
3. Do you have type 1 diabetes, or have you ever had an episode of diabetic ketoacidosis (DKA) or a hyperosmolar state/coma (dangerously high blood sugar)?
4. Have you ever been diagnosed with pancreatitis (inflammation of the pancreas)?
5. Are you currently taking, or have you taken in the last 3 months, steroid pills or steroid shots regularly for more than 2 weeks? Or do you have an active autoimmune condition (like lupus or rheumatoid arthritis) that your doctor feels may need steroid treatment during the study?
6. Do you have an active cancer, or have you been treated for cancer and are not yet 5 years cancer-free? (Exceptions: basal cell or squamous cell skin cancer, early-stage cervical cancer that has not spread (carcinoma in situ), or early-stage/Grade 1 prostate cancer are okay.)
7. Have you had an organ transplant, or are you currently on a waiting list for one? (Corneal transplants are okay.)
8. In the last 3 months, have you had a heart attack, unstable chest pain (angina), a heart procedure to open blocked arteries, a stroke, or a hospital stay for heart failure?
9. Has a doctor ever told you that you have the most severe class of heart failure?
10. Have you ever been diagnosed with bipolar disorder or schizophrenia?
11. Have you been diagnosed w/anxiety or depression & have been taking the same dose of medication for the last 2 years?
12. Is there anything else about your health, or any substance use (recreational drugs or alcohol), that a doctor might feel could make it unsafe for you to participate or make it hard for you to follow study instructions?
13. Do you have a known allergy or intolerance to GLP-1 medications (a class that includes drugs like Ozempic®, Wegovy®, Trulicity®, or Victoza®)?
14. Has a doctor told you that your weight is related to a hormone condition (such as Cushing syndrome) or a genetic condition (such as Prader-Willi syndrome)?
15. In the last 3 months, have you had an unplanned weight change of more than 11 pounds (5 kg)?
16. In the last 6 months, have you had a severe low blood sugar episode, or times when you couldn’t tell your blood sugar was low?
17. Are you currently being treated, or scheduled to be treated, for diabetes-related eye disease (such as with laser treatment or eye injections)?
18. Do you have a diagnosed stomach-emptying problem (such as gastroparesis, where the stomach empties too slowly, or a blockage), or do you regularly take medication that affects digestion or stomach emptying?
19. Do you have any surgery planned (other than a minor procedure) during the next year and a half?
20. Have you used any prescription weight-loss drugs, over-the-counter weight-loss products, or herbal/nutritional weight-loss supplements in the last 6 months?
21. Have you started or changed the dose of any of the following within the last 3–12 months: tricyclic antidepressants, antipsychotic medications, or mood stabilizers?
22. Have you used insulin, or certain other diabetes medications that are not allowed in this study, within the last 3 months? (Exceptions: insulin for diabetes during pregnancy (gestational diabetes), or short-term insulin for 14 days or less during a hospital stay or surgery, are okay.)
23. Have you started using an implanted or injected birth control method in the last 18 months? (IUDs are okay.)
24. Do you, or a parent, sibling, or child, have a history of medullary thyroid cancer or a condition called MEN2 (multiple endocrine neoplasia type 2)?
25. Are you currently enrolled in another research study involving a medication or medical device, or have you taken part in one and received treatment within the last 3 months?
26. Are you, or an immediate family member (spouse, parent, child, sibling), an employee of a clinical research site, sponsor company, or CRO (contract research organization) involved in this study?
27. Have you previously taken part in a study of this same medication, ASC30, and either completed it or withdrawn after receiving at least one dose?

Answers Must Be YES

1. Are you reliable and willing to follow study procedures for the length of the study?
2. Are your veins easy enough to access for blood draws?
3. If female and unable to become pregnant, are you one of the following:
   • Postmenopausal (no menstrual period for 12 months without another medical cause), OR
   • Permanently sterilized by a documented surgery: hysterectomy (removal of the uterus), removal of both fallopian tubes and both ovaries, removal of both fallopian tubes, or removal of both ovaries, OR
   • Permanently unable to become pregnant due to another medical cause
4. If female and able to become pregnant, do you agree to use 2 forms of the following birth control methods:
   • Combination birth control pill
   • Progestin-only birth control
   • Birth control implant, injection, or patch (only for women under 198 pounds or 98 kg)
   • Total abstinence, vasectomy, or fallopian tube implants
   • Combined birth control vaginal ring, or IUD
   • Male or female condoms with spermicide, diaphragm with spermicide, or cervical cap with spermicide
   • Tubal ligation (“tubes tied”)