OPT101 Phase 2 subcutaneous PK and pilot efficacy in T1D
Recruiting US Phase 2 of subcutaneous OPT101 three times weekly. Part A is open-label dose-finding; Parts B and C are 48-week placebo-controlled C-peptide cohorts. This is the registered follow-on to the completed Phase 1b. No efficacy results.
Primary endpoints
- Change from baseline to week 48 in mixed-meal stimulated C-peptide
Results so far
No results. Recruiting; estimated n=72; actual start 10 April 2026; estimated primary completion 31 May 2026 (that date has passed; the registry is still recruiting and has not posted results) and study completion 19 August 2028. Last registry update 6 April 2026. A passed estimated primary-completion date is not a result.
The full picture
Phase 1b (NCT05428943) used intravenous OPT101 and posted small safety tables with no C-peptide advantage over placebo. This Phase 2 switches to a subcutaneous formulation, three times a week, and asks whether a year of the highest tolerated dose changes mixed-meal C-peptide.
Part A is 18 people, open-label, two weeks. Parts B and C are randomised 2:1 drug versus placebo for 48 weeks (27 people each as designed). Glucose units in the protocol use mixed-meal C-peptide in ng/mL; 0.2 ng/mL is about 0.07 nmol/L. A registered, recruiting protocol is not an efficacy result.