Weight Management & Type 2 Diabetes Self-Scheduler

Qualified participants: 

• Between 18 and 79 years old
• BMI of 27 or higher
• Diagnosed with type 2 diabetes, with a recent HbA1c between 6.5% and 10%
• Has been on a stable diabetes treatment plan (diet/exercise only, or up to 3 pills — NO injections) for at least 90 days
• Willing and able to attend study visits and follow procedures for the full ~18-month study

Answers Must Be NO 

• Have you ever had a severe allergic reaction to food, medication, or otherwise that required an ER visit or epinephrine (EpiPen)? 
• Have you used any prescription or over-the-counter weight-loss medications in the last 6 months?” This includes: Wegovy, Ozempic, Rybelsus, Zepbound, Mounjaro, Saxenda, Contrave, Qsymia, phentermine (Adipex, Lomaira), orlistat (Xenical/Alli), or any compounded weight-loss medication. 
• Do you currently use insulin, or any injectable diabetes medication (like Ozempic, Trulicity, Mounjaro, Victoza, Byetta)? 
• Have you ever been diagnosed with type 1 diabetes, or told you had diabetic ketoacidosis (DKA) or a hyperosmolar diabetic coma? 
• Has your body weight changed by more than 11 pounds (5 kg), up or down, in the last 3 months? 
• Have you had, or are you planning, any weight-loss surgery or procedure — such as gastric bypass, gastric sleeve, gastric balloon, or a similar device-based procedure?
  (Note: cosmetic procedures like liposuction, CoolSculpting/cryolipolysis, or Kybella done more than 1 year ago do NOT exclude — flag for clinical review if this comes up.) 
• Do you have a history of drug or alcohol use disorder? Would you test positive on a drug screen for anything other than marijuana? 
• Are you currently pregnant, breastfeeding, or planning to become pregnant during the next ~18 months? (Female participants only) 
• In the last 6 months, have you had a severe low blood sugar episode requiring help from someone else, or low blood sugar you couldn’t feel coming on? 
• Are you currently being treated, or planning treatment, for diabetic eye disease (diabetic retinopathy) or swelling in the back of the eye (macular edema) — for example, laser treatment or eye injections? 
• In the last 6 months, have you had a heart attack, stroke, mini-stroke (TIA), or a procedure to open blocked leg/arm arteries? 
• Have you been diagnosed with heart failure that significantly limits your daily activity (shortness of breath with minimal effort or at rest)? 
• Do you have significantly reduced kidney function, or has a doctor told you your kidneys are working at less than 30% of normal? 
• Have you been diagnosed with Crohn’s disease, ulcerative colitis, chronic malabsorption, or a bowel blockage (ileus)? 
• Do you have hepatitis (any type), cirrhosis, or another liver disease? Have you tested positive for hepatitis B or C? 
• Have you tested positive for HIV, or do you currently have an active COVID-19 infection? 
• Do you or a close blood relative (parent, sibling, child) have a history of medullary thyroid cancer or Multiple Endocrine Neoplasia type 2 (MEN2)? 
• Do you have a thyroid condition that isn’t well-controlled with medication? (Stable, treated hypothyroidism for 60+ days is fine.) 
• Have you been treated for any cancer in the last 5 years? (Minor skin cancers and certain early-stage cervical/prostate cancers are ok) 
• Do you have a blood disorder such as sickle cell disease or hemolytic anemia? 
• In the last 2 years, have you had an active or unstable diagnosis of major depression, schizophrenia, bipolar disorder, or another serious mood or anxiety disorder? 
• Have you ever attempted suicide or had thoughts of suicide with a specific plan or intent in the last month? 
• Have you had pancreatitis, or do you have a history of gallstones? (Prior gallbladder removal more than 90 days ago is fine) 
• Have you had an organ transplant, or are you waiting for one? (Corneal transplants are ok.) 
• Have you used oral or injectable steroid medications (like prednisone) for more than 2 weeks in the last 3 months? (Inhalers, nasal sprays, skin creams, and eye drops don’t count.) 
• Have you started or changed the dose of any mood medication in the last 6 months — such as amitriptyline, mirtazapine, olanzapine, quetiapine, lithium, or valproic acid? (Stable for 6+ months on the same dose is generally ok) 
• Are you currently enrolled in another research study, or have you participated in one in the last 60 days? Have you ever taken aleniglipron before? 
• Do you have any other serious ongoing health condition — heart, lung, kidney, blood, digestive, immune, skin, or nerve-related — that a doctor has said could make participating in a research study risky for you? 

Answers Must Be YES 

• Are you willing to use an effective method of contraception per study requirements, if of childbearing potential (or partner could become pregnant). Must use a highly effective method of contraception from signing the consent form until ≥1 week after the last dose of study drug.
• Oral or intravaginal combined (estrogen- and progestogen-containing) hormonal contraceptives
• Oral, injectable, or implantable progestogen-only hormonal contraceptives
• IUD, IUS, vasectomized male partner
• Are you willing to avoid donating sperm/eggs and not freeze/donate ova during the study (as applicable)
• Are you willing to avoid grapefruit, Seville oranges, and tangelos for the study?
• Are you able to understand and sign informed consent?