Roche Shocks Clinicians by Halting Acmopatide Phase 3 in Type 1 Diabetes Despite Stellar Phase 2 Efficacy

Roche Shocks Clinicians by Halting Acmopatide Phase 3 in Type 1 Diabetes Despite Stellar Phase 2 Efficacy

At the American Diabetes Association (ADA) Scientific Sessions in New Orleans (June 5-8, 2026), researchers presented highly anticipated late-breaking Phase 2 results for Roche's once-daily dual GLP-1/GIP receptor agonist acmopatide (formerly CT-868, acquired via Carmot Therapeutics) in overweight or obese patients with Type 1 diabetes (T1D). The trial demonstrated remarkable glycemic, metabolic, and cardiovascular efficacy. However, in a move that shocked the clinical community, Roche announced that it will not pursue Phase 3 development for acmopatide in the Type 1 diabetes population, opting instead to abandon this therapeutic indication.¹

Robust Phase 2 Clinical Efficacy

The Phase 2 randomized, double-blind trial evaluated 111 adults aged 18 to 65 with T1D, a baseline HbA1c of 7.0% to 10.0%, and a BMI of 27 kg/m² or higher. Over 16 weeks, patients received once-daily subcutaneous doses of acmopatide (1.8 mg, 4.1 mg, or 6.6 mg) or placebo as an adjunct to insulin:

• Glycemic Control: The 4.1 mg dose of acmopatide achieved a statistically significant 0.59 percentage point reduction in HbA1c compared to a 0.25 percentage point decline with placebo ($P < 0.05$). Furthermore, 55.6% of patients in the 4.1 mg arm and 43.5% in the 6.6 mg arm reached the recommended target HbA1c of <7.0% (vs. 33.3% for placebo).
• Weight Loss: Patients experienced dramatic, dose-dependent weight loss, losing 6.67% of body weight in the 6.6 mg group, 6.43% in the 4.1 mg group, and 3.26% in the 1.8 mg group, compared to a 0.29% weight gain in the placebo arm ($P < 0.01$ for all).
• Insulin Sparing: Total daily insulin requirements were reduced by 14.92 units in the 6.6 mg group.
• Cardiovascular Benefits: Systolic blood pressure decreased by 8.4 mmHg with the 6.6 mg dose and 5.0 mmHg with the 4.1 mg dose.
• Safety Profile: The therapy was generally well-tolerated. Gastrointestinal adverse events (nausea, constipation, vomiting) were mild-to-moderate. Crucially, there were no reports of severe hypoglycemia (level 3) or diabetic ketoacidosis (DKA), which have historically plagued other non-insulin adjuncts in T1D.

Explaining the Clinical Backlash

Because insulin-treated T1D patients suffer from severe metabolic challenges and have zero approved incretin-based metabolic therapies, the decision by Roche to halt acmopatide's T1D development program was met with intense disappointment from clinical investigators and patient advocates. Leading endocrinologists emphasized that T1D patients are being left behind in the incretin revolution.

Dr. Jeremy Pettus, MD, associate professor of medicine at UC San Diego and a prominent T1D specialist, expressed the collective frustration of the endocrine community:

"I think I speak for my other colleagues and speakers that we’re very disappointed with this announcement. As somebody that’s been fighting this cause for a long time, living with type 1 diabetes, we have such an urgent need for metabolic therapies for type 1 diabetes. This is quite devastating, to be honest."

Future Outlook and Incretin Pipelines in T1D

While acmopatide's journey in T1D has ended, the proof-of-concept data validates the potential of dual GLP-1/GIP agonists as powerful metabolic adjuncts in T1D. The spotlight now shifts entirely to Eli Lilly, which is actively conducting the Phase 3 SURPASS T1D-1 trial evaluating its dual agonist tirzepatide (Mounjaro) as an adjunct therapy in overweight/obese patients with Type 1 diabetes. The SURPASS T1D-1 trial is scheduled for completion in November 2026.