Roche (ROG) Study update summary

Strategic overview and market context

• Ambition to become a top 3 player in obesity by 2030, focusing on innovative therapies and differentiated offerings.

• Strategy emphasizes rapid advancement of late-stage assets, combination therapies, and patient-centric care delivery.

• Only 10–15% of eligible US patients receive branded anti-obesity medication, with treatment often starting late in disease progression.

• Market growth is driven by new patient inflow, cyclical treatment patterns, improved persistence, and education.

• Patient needs vary by disease stage, requiring tailored solutions from high-efficacy treatments for severe cases to gentler options for early intervention.

Pipeline and study updates

• Pipeline includes enicepatide (GLP-1/GIP RA), petrelintide (amylin analog), their combination, and oral small molecule CT-996, all in various stages of clinical development.

• Enicepatide (CT-388) advanced to phase III for chronic weight management, with two pivotal studies (Enith1 and Enith2) in people with and without type 2 diabetes.

• Petrelintide completed phase II (ZUPREME-1) with promising results and will enter phase III as monotherapy and in combination with enicepatide (SYNERGY/ZYNERGY trial).

• Oral GLP-1 agonist CT-996 is in phase II for obesity and type 2 diabetes, with a phase III decision expected by year-end and phase II data expected H2 2026.

• The portfolio addresses diverse patient needs, leveraging monotherapy, combination approaches, and integration of diagnostics for personalized care.

Enicepatide (CT-388) phase II results

• 48-week, double-blind, placebo-controlled US study in adults with overweight/obesity (no diabetes), testing five doses (4–24 mg).

• Highest dose (24 mg) achieved 22.7% mean weight loss at 48 weeks, with 26% losing ≥30% body weight and 47.8% achieving ≥20% weight loss.

• 87% of participants on 24 mg achieved ≥10% weight loss.

• 73% of participants with pre-diabetes at baseline reverted to normal glycemia at week 48.

• Safety profile consistent with incretin-based therapies; most GI adverse events were mild to moderate and discontinuation rates were low.