Trials, Program Spotlights
Clinical Trial Programs
Multi-trial dossiers covering peptide programs. What each trial answered, how the results combined, and where the program sits in the regulatory record.
SURPASS
Eli Lilly, Tirzepatide
HbA1c reductions of approximately 1.9 to 2.6 percentage points across the five trials at the highest dose; body-weight reductions of 7 to 13 kg; superiority over semaglutide 1 mg on both glycemic and weight endpoints in SURPASS-2.
Open spotlightSURMOUNT
Eli Lilly, Tirzepatide
SURMOUNT-1 reported approximately 22.5% mean body-weight reduction at 72 weeks with tirzepatide 15 mg in adults with obesity without T2DM. SURMOUNT-2 demonstrated approximately 15.7% weight reduction in adults with T2DM and obesity. SURMOUNT-OSA showed significant reductions in apnea-hypopnea index supporting the obstructive sleep apnea indication.
Open spotlightSTEP
Novo Nordisk, Semaglutide 2.4 mg subcutaneous
STEP-1 reported approximately 14.9% mean body-weight reduction at 68 weeks versus 2.4% with placebo. STEP-3 (with intensive behavioral therapy) achieved approximately 16.0% weight reduction. STEP-8 showed significantly greater weight loss with semaglutide 2.4 mg than with liraglutide 3.0 mg. Reimbursement and access vary substantially by country.
Open spotlightSUSTAIN
Novo Nordisk, Semaglutide injectable (0.5 mg and 1.0 mg)
HbA1c reductions of approximately 1.0 to 1.8 percentage points across the program at the 1.0 mg dose; weight reductions of 3 to 6 kg. SUSTAIN-6 demonstrated a 26% relative reduction in the composite MACE endpoint (CV death, non-fatal MI, non-fatal stroke) versus placebo, driven primarily by non-fatal stroke reduction.
Open spotlightPIONEER
Novo Nordisk, Oral semaglutide (with SNAC absorption enhancer)
HbA1c reductions of approximately 0.8 to 1.4 percentage points at the 14 mg dose across the program; weight reductions of 2 to 4 kg. PIONEER-6 demonstrated cardiovascular non-inferiority versus placebo in a high-risk T2DM population. Efficacy is somewhat attenuated compared with the subcutaneous form due to bioavailability constraints inherent to oral delivery.
Open spotlightSELECT
Novo Nordisk, Semaglutide 2.4 mg subcutaneous
20% relative reduction in the primary composite MACE endpoint (CV death, non-fatal MI, non-fatal stroke) with semaglutide 2.4 mg versus placebo over a median follow-up of approximately 40 months in adults with overweight/obesity and established CVD without diabetes.
Open spotlightLEADER
Novo Nordisk, Liraglutide
13% relative reduction in the three-component MACE composite (CV death, non-fatal MI, non-fatal stroke) with liraglutide versus placebo over a median follow-up of 3.8 years; hazard ratio 0.87 (95% CI 0.78 to 0.97). The cardiovascular death component drove the overall result.
Open spotlightSCALE
Novo Nordisk, Liraglutide 3.0 mg
Approximately 8.0% mean body-weight reduction in the SCALE Obesity and Prediabetes trial versus 2.6% with placebo at 56 weeks; approximately 6.0% in adults with T2DM; significant weight loss maintenance in SCALE Maintenance; and modest improvements in sleep apnea severity in SCALE Sleep Apnea.
Open spotlight