Effect of Tirzepatide versus Placebo in Participants with Type 2 Diabetes Who Have Obesity or Are Overweight (SURMOUNT-2)

Phase 3

• Conditions: Participants with type 2 diabetes who have obesity or are overweight

• Registration Number: JPRN-jRCT2031200440
• Lead Sponsor: Masaki Takeshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

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/square meter
-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Percent Change from Randomization in Body Weight<br>2. Percentage of Participants Who Achieve >=5% Body Weight Reduction from Randomization