Living with Type 2 Diabetes and excess weight? Consider a research study.

Requirements

Participants must meet the following inclusion criteria to be eligible for this clinical trial:

• Adults ages 18 to 79
• Have been diagnosed with Type 2 diabetes
  • Are on a stable treatment for T2DM for at least 90 days prior to screening, consisting of:
  • Either diet/exercise alone
    OR
  • Up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase-4 inhibitors
• Use of other injectable therapies (GIP/GLP-1RA or insulin) is not permitted
• Are living with obesity, OR
• Are affected by excess weight and have at least one weight-related health condition
• BMI: >27kg/m2
• Additional eligibility criteria apply and will be reviewed by the study team.
• Must not have:
• Diabetes related
  • type 1 diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM
  • had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 180 days prior to screening
  • Are not currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laser photocoagulation or intravitreal injections of antivascular endothelial growth factor inhibitors
• Obesity Related:
  • Self-reported change in body weight >5 kg (11 pounds) within 3 months before screening
  • Use of medications intended to promote weight loss (ex: Ozempic®/Wegovy®/Zepound™/Mounjaro®), within 6 months prior to screening
  • Have prior or planned surgical or non-surgical treatment for obesity. However, the following are allowed if performed >1 year before screening:
    • Liposuction
    • Abdominoplasty
    • Cryolipolysis
    • Injection lipolysis (e.g., Kybella®)
    • Radiofrequency lipolysis (e.g., Vanquish)
    • Laser lipolysis (e.g., SculpSure)
• Have or plan to have endoscopic and/or device-based therapy for obesity including, but not limited to, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal endoluminal liner. Note: Prior device-based therapy is acceptable if device removal was more than 180 days prior to Visit 1.
• Have obesity induced by other endocrine disorders (such as Cushing’s syndrome, Prader-Willi
  syndrome, or melanocortin 4 receptor deficiency).
• Health status is further evaluated by reviewing medical history, screening assessments, and visit with physician
• Don’t meet one of the criteria above? You may qualify for another study – please explore the full list at here https://trialmed.com/find-a-study/

About study

Researchers are evaluating an investigational oral GLP-1 medication for adults living with Type 2 diabetes and obesity, or Type 2 diabetes and overweight.

Type 2 diabetes and excess weight often occur together and can affect long-term health. Researchers continue to study new treatment options that may help support blood sugar management, weight management, and overall metabolic health.

This study is evaluating an investigational GLP-1 medication that is taken by mouth once daily. Unlike many GLP-1 medications that require injections, the study medication is an oral tablet. Researchers hope to learn more about its long-term safety, tolerability, and effectiveness when used alongside healthy lifestyle changes.