Clinical Trial Data for tirzepatide
Extensive clinical trials have established tirzepatide’s significant efficacy in glycemic control for type 2 diabetes, as well as its substantial effect on weight reduction.
SURPASS Trials: Type 2 Diabetes
The global SURPASS trials highlighted tirzepatide’s remarkable ability to deliver consistent and substantial improvements in both glycemic control and weight reduction in patients with Type 2 Diabetes. This efficacy and safety were evaluated across a broad spectrum of adults, including its use as a monotherapy and in combination with other anti-diabetic medications.
SURPASS-1
(Monotherapy)
Aim: Evaluation of tirzepatide monotherapy vs. placebo in adults with type 2 diabetes inadequately managed by diet and exercise, who are naive to injectable diabetes therapy.
Key Finding: Tirzepatide demonstrated superior HbA1c and weight reductions compared to placebo.
SURPASS-2
(vs. Semaglutide)
Aim: To compare tirzepatide vs. semaglutide (a GLP-1 RA) as an add-on to metformin in adults with type 2 diabetes.
Key Finding: Tirzepatide demonstrated superior HbA1c and weight reductions compared to semaglutide.
SURPASS-3
(vs. Insulin Degludec)
Aim: To compare tirzepatide vs. insulin degludec (a basal insulin) as an add-on to metformin with or without SGLT2 inhibitors in adults with type 2 diabetes.
Key Finding: Tirzepatide showed superior HbA1c and weight reductions compared to insulin degludec.
SURPASS-4
(vs. Insulin Glargine)
Aim: To compare tirzepatide versus insulin glargine as an add-on to any combination of metformin, sulfonylurea, or SGLT2 inhibitor in adults with type 2 diabetes and established cardiovascular disease or high cardiovascular risk.
Key Finding: Tirzepatide demonstrated superior and sustained glycemic control and weight loss than glargine in patients with long-standing type 2 diabetes and high cardiovascular risk.
SURPASS-5
(vs. Placebo, with Basal Insulin)
Aim: To evaluate the efficacy and safety of tirzepatide added to insulin glargine with or without metformin in patients with type 2 diabetes with inadequate glycemic control.
Key Finding: Adding tirzepatide to insulin glargine, compared to placebo, led to significant improvements in glycemic control.
SURPASS-6
(Adding Tirzepatide vs Prandial Insulin Lispro to Basal Insulin)
Aim: To evaluate the efficacy and safety of tirzepatide vs insulin lispro as add-on to insulin glargine in adults with inadequately controlled type 2 diabetes.
Key Finding: Tirzepatide demonstrated reductions in HbA1c and body weight with less hypoglycemia.
SURPASS-CVOT
(Cardiovascular Outcomes Trial)
Aim: To evaluate the cardiovascular efficacy and safety of tirzepatide compared to dulaglutide (a GLP-1 RA) in patients with type 2 diabetes and established atherosclerotic cardiovascular disease.
Key Finding: Tirzepatide reduced the risk of cardiovascular death, heart attack, or stroke by 8% compared to dulaglutide, thereby meeting the prespecified criteria for non-inferiority. Additionally, tirzepatide was associated with a 16% lower rate of all-cause mortality compared to dulaglutide.
SURMOUNT Trials: Weight Management
The SURMOUNT trials investigate tirzepatide’s efficacy and safety for chronic weight management in adults with obesity or overweight with weight-related comorbidities. These trials primarily focus on the percentage reduction in body weight.
SURMOUNT-1
(Obesity, without Type 2 Diabetes)
Aim: To evaluate the efficacy of tirzepatide for weight management in adults without type 2 diabetes who have obesity (BMI ≥30) or are overweight (BMI ≥27) with at least one weight-related comorbidity.
Key Finding: Tirzepatide provided substantial and sustained reductions in body weight.
SURMOUNT-2
(Obesity, with Type 2 Diabetes)
Aim: To evaluate tirzepatide for weight management in adults with obesity or overweight with type 2 diabetess.
Key Finding: Tirzepatide provided substantial and sustained reductions in body weight in adults with a BMI of 27 kg/m² or higher and type 2 diabetes, in addition to clinically meaningful improvements in cardiometabolic risk factors and glycemic control.
SURMOUNT-3
(Weight Management, Post Intensive Lifestyle Intervention)
Aim: To evaluate the efficacy and safety of tirzepatide following an intensive lifestyle intervention lead-in phase in adults with obesity or overweight.
Key Finding: Tirzepatide demonstrated clinically meaningful additional body weight reductions in adults with overweight or obesity following initial weight loss with intensive lifestyle intervention.
SURMOUNT-4
(Weight Management, Treatment Continuation/Withdrawal)
Aim: To evaluate the effect of continuing tirzepatide versus switching to placebo after an initial 36-week treatment period in adults with obesity or overweight.
Key Finding: Continued tirzepatide treatment maintained and furthered weight loss, while those switched to placebo experienced weight regain
SURMOUNT-5
(Weight Management, vs. Semaglutide)
Aim: To compare the efficacy and safety of tirzepatide versus semaglutide for weight management in adults without diabetes who have obesity or are overweight with at least one weight-related comorbidity.
Key Finding: Tirzepatide was superior to semaglutide in reducing body weight and waist circumference.
SURMOUNT-OSA
(Obstructive Sleep Apnea)
Aim: To evaluate tirzepatide for the treatment of moderate-to-severe Obstructive Sleep Apnea (OSA) in adults with obesity.
Key Finding: Tirzepatide demonstrated clinically meaningful improvements in sleep-disordered breathing, reduced perceived sleep disturbances and sleep-related impairments, and lowered common cardiovascular risk factors associated with obstructive sleep apnea.