Roche’s CT-388 Delivers 22.5% Placebo-Adjusted Weight Loss in Phase II Obesity Trial

Roche’s CT-388 Delivers 22.5% Placebo-Adjusted Weight Loss in Phase II Obesity Trial

By, Admin 28 January 2026

Roche reported positive topline results from CT388-103, a Phase II study of CT-388, its investigational dual GLP-1/GIP receptor agonist for obesity. The trial showed clinically meaningful and durable weight loss with once-weekly dosing. No weight-loss plateau was observed at 48 weeks.

Key efficacy highlights

At the highest tested dose (24 mg):

  • 22.5% placebo-adjusted weight loss (efficacy estimand)
  • 18.3% placebo-adjusted weight loss (treatment-regimen estimand; p < 0.001)
  • Clear dose–response relationship

Weight-loss responder rates at Week 48:

  • 95.7% achieved ≥5% loss
  • 87.0% achieved ≥10% loss
  • 47.8% achieved ≥20% loss
  • 26.1% achieved ≥30% loss

Strong metabolic signal in pre-diabetes

Among participants with pre-diabetes at baseline:

  • 73% on CT-388 24 mg achieved normal blood glucose
  • 7.5% on placebo achieved normal blood glucose

This suggests potential benefit beyond weight reduction alone.

Safety and tolerability

CT-388 was generally well tolerated.

  • Most gastrointestinal events were mild to moderate
  • Discontinuation due to adverse events:
    • 5.9% with CT-388
    • 1.3% with placebo

Safety was consistent with the incretin drug class.

What Roche says?

Levi Garraway, MD, PhD, Roche’s chief medical officer:

The robust weight loss combined with a well-tolerated safety profile reinforces our confidence as we advance to Phase III trials.

What’s next for CT-388?

Roche has designated CT-388 as a fast-track asset.

Ongoing and planned development:

  • Additional Phase II study in obesity with type 2 diabetes (CT388-104)
  • Phase III obesity program (Enith1 and Enith2) expected to start this quarter
  • Evaluation as a potential combination partner with petrelintide

Why CT-388 may be differentiated?

CT-388 is designed with:

  • Potent GLP-1 and GIP receptor activation
  • Minimal ß-arrestin recruitment
  • Reduced receptor internalisation and desensitisation

This biased signaling profile is expected to support prolonged pharmacologic activity.

Bottom line

CT-388 shows best-in-class-range weight loss, durable response through 48 weeks, and a tolerable safety profile. Roche is positioning it as a cornerstone of its cardiometabolic pipeline and a future combination backbone.

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