By Fineline Cube Roche (SWX: ROG, OTCMKTS: RHHBY) announced positive topline results from its Phase II clinical trial (CT388‑103) for CT‑388, an investigational GLP‑1/GIP receptor agonist in obesity. The once‑weekly subcutaneous injection achieved a placebo‑adjusted weight loss of 22.5% at 48 weeks, with weight reduction yet to reach a plateau and a clear dose‑response relationship observed.
Clinical Trial Results & Key Findings
| Metric | Result |
|---|---|
| Trial | CT388‑103 Phase II |
| Drug | CT‑388 (GLP‑1/GIP receptor agonist) |
| Dosing | Once‑weekly SC, titrated to maximum 24 mg |
| Primary Endpoint | Placebo‑adjusted weight loss |
| Weight Loss at 48 Weeks | 22.5% (Efficacy Estimand) |
| Dose Response | Clear relationship observed |
| Status | Weight loss not yet plateaued |
Drug Profile & Mechanism of Action
- Dual Agonist: CT‑388 selectively targets and activates both GLP‑1 and GIP receptors to regulate energy balance, reduce appetite, and modulate blood glucose
- Biased Signaling: Designed to potently activate both receptors while inducing minimal β‑arrestin recruitment
- Reduced Desensitization: This signaling bias significantly reduces receptor internalization and subsequent desensitization, expected to lead to more durable pharmacological activity
- Competitive Edge: Differentiates from competitors by potentially offering sustained efficacy with lower receptor desensitization
Market Impact & Commercial Outlook
- Global Obesity Market: Valued at $15 billion : 2025, projected to exceed $40 billion : by 2030
- Competition: Novo Nordisk’s Wegovy/Ozempic and Eli Lilly’s Zepbound/Mounjaro dominate; Roche’s CT‑388 enters as a next‑generation dual agonist with differentiated signaling profile
- Clinical Differentiation: 22.5% weight loss at 48 weeks compares favorably to existing therapies; durability advantage may support premium pricing
- Strategic Value: Validates Roche’s re‑entry into metabolic disease after earlier setbacks; positions company as credible alternative to incumbents
- Next Steps: Phase III trial initiation expected Q3 2026 ; potential NDA filing 2028 ; management suggests readiness for global development program
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and commercial prospects for CT‑388. Actual results may differ due to clinical trial outcomes, competitive dynamics, and regulatory review processes.-Fineline Info & Tech