TRANSCEND-T2D-1: Type 2 Diabetes Glycemic Control Trial

Study Overview

TRANSCEND-T2D-1 is the pivotal Phase 3 trial evaluating retatrutide for glycemic control in adults with type 2 diabetes. The TRANSCEND (Triple Receptor Agonist for Normalization of Sustained Cardiometabolic Endpoints in Diabetes) program is separate from the TRIUMPH obesity program, focused specifically on the diabetes indication.

Building on Phase 2 Diabetes Data

The Phase 2 type 2 diabetes trial (NCT04867785) demonstrated:

• HbA1c reduction of up to -2.02% at 12 mg/36 weeks
• 71% of participants achieved HbA1c <7% at the highest dose
• Significant weight loss (-16.9% at 12 mg) concurrent with glycemic improvement
• Active comparator (dulaglutide 1.5 mg) achieved only -1.4% HbA1c reduction

Study Design

Population

Adults aged 18-75 with:

• Type 2 diabetes (HbA1c 7.0-10.5%)
• Currently on metformin monotherapy (stable dose for at least 3 months)
• BMI ≥25 kg/m²

Treatment Arms

• Retatrutide 8 mg (with dose escalation)
• Retatrutide 12 mg (with dose escalation)
• Placebo
• Active comparator (likely semaglutide 1.0 mg or tirzepatide)

Endpoints

Primary endpoints:

• Change in HbA1c from baseline at 40 weeks
• Proportion achieving HbA1c <7%

Key secondary endpoints:

• Proportion achieving HbA1c <6.5% and <5.7%
• Body weight change
• Fasting plasma glucose change
• Time in glucose range (CGM substudy)
• Composite metabolic endpoint (HbA1c + weight + blood pressure)

Significance

TRANSCEND-T2D-1 will determine whether retatrutide can achieve regulatory approval for type 2 diabetes — an indication that is complementary to but distinct from the obesity indication pursued in the TRIUMPH program. Approval for both indications would significantly broaden retatrutide’s potential patient population.