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Phase 2 study comparing the oxyntomodulin analog, LY2944876 (TT401), to once-weekly exenatide and to placebo in patients with type 2 diabetes

Study Design

• Patient population: 420 type 2 diabetes patients
• Study arms: 6 (placebo, 4 doses of TT401, exenatide ER)
• Treatment periods: a 12-week blinded treatment period followed by a 12-week unblinded treatment
• Status: COMPLETED (Feb 2016) - Link to press release

Primary Outcome Measure

• Change from baseline in HbA1c @ weeks 12 and 24

For more information, please visit ClinicalTrials.gov.


Double-blind, placebo-controlled, proof-of-concept study of TT401

Study Design

• Patient population:
   - 50 obese diabetic patients (five dosing levels) on stable doses of metformin
   - 10 obese non-diabetic patients (one dose level)
• Once-weekly dosing for 5 weeks
• Status: COMPLETED (Apr 2013) - Link to press release

Key Findings

• TT401-treated patients in the three highest dose groups showed statistically significant reduction
in mean fasting plasma glucose relative to placebo
• Statistically significant mean body weight reduction relative to baseline occurred in the three
highest dose groups
• A similar reduction in body weight in the obese non-diabetic cohort
• An acceptable safety and tolerability profile at all doses
• Decreased appetite was the most common adverse event noted
• Some subjects in the highest three dose groups experienced mild nausea and vomiting, which are
consistent with studies of other GLP-1 agonist drug candidates

© 2015 Transition Therapeutics Inc.