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Phase III

SURMOUNT-2

  • Study HIC#:2000030159
  • Last Updated:08/31/2021

Do you struggle with weight and have Type 2 Diabetes?

The SURMOUNT-2 Trial

If you are 18 years of age or older and are overweight or have obesity with Type 2 Diabetes, you may qualify for a clinical trial evaluating a once weekly medication which may help with weight loss. The SURMOUNT-2 trial is funded by the Eli Lilly and the study medication (tirzepatide vs. placebo) is provided at no cost to qualifying participants. Participants cannot be taking insulin and must have a HgbA1c between 7-10% to qualify.

If you struggle with your weight, have type 2 diabetes, and would like to learn more, contact us to see if you qualify and are eligible to participate, please call 203-764-6649 or email Yweight@yale.edu and please provide the best contact phone number where we can reach you.

  • Age18 years and older
  • GenderBoth
  • Start Date08/10/2021
  • End Date06/19/2023

Eligibility Criteria

Inclusion Criteria:

  • Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
  • Have a BMI of ≥27 kg/m²
  • Are overweight or have obesity
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
  • Are at least 18 years of age and age of majority per local laws and regulations

Exclusion Criteria:

  • Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
  • Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
  • Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
  • Have self-reported change in body weight >5kg within 3 months prior to screening
  • Have had a history of chronic or acute pancreatitis
  • Change in body weight greater than 5 kg within 3 months prior to starting study
  • Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
  • Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
  • Any lifetime history of a suicide attempt