Efpeglenatide: A New Once-Weekly GLP-1 Injection for Type 2 Diabetes
By Jeemin Kwon
By Jeemin Kwon
Phase 3 clinical trial currently recruiting 400 adults with type 2 diabetes
Clinical Trials Identifier: NCT03353350
Trial name: Efficacy and Safety of Efpeglenatide Versus Placebo in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise
Diabetes type: Type 2
What the trial is testing: The aim is to assess the benefit of once-weekly efpeglenatide, an injectable GLP-1 agonist in development by Sanofi. If the trial outcomes are positive, efpeglenatide will be one step closer to regulatory approval. FDA-approved GLP-1 agonists include Byetta/Bydrueon, Adlyxin, Trulicity, Victoza, and Ozempic. (Bydureon, Trulicity, and Ozempic are all once-weekly).
What the trial is measuring: Trial participants will be divided into four groups: low dose, middle dose, and high dose efpeglenatide, plus a group getting placebo (a “nothing” injection). Researchers will compare changes in A1c at the end of 30 weeks. Beyond that main outcome, the trial will extend to 56 weeks to measure changes in A1c, fasting glucose, self-monitored blood sugar, and weight.
Why is this new/important? Sanofi’s current GLP-1 agonist, Adlyxin, is taken once daily. It is also found in Soliqua, a basal insulin + GLP-1 combination injection. Efpeglenatide, however, is active in the body for much longer, reducing the burden of injections to once-weekly.
Trial length: The trial is expected to last 65 weeks, including screening and safety follow-up
Trial locations: Trial locations include Birmingham, Alabama; Glendale, California; Lincoln, Nebraska; Bridgeton, New Jersey; Hatboro, Pennsylvania; and Holladay, Utah
Do you qualify? Inclusion criteria include:
18 years and older
Diagnosed with type 2 diabetes
A1c between 7% and 10%
Select exclusion criteria include:
History of gastrointestinal disease associated with prolonged nausea and vomiting
History of chronic pancreatitis
Retinopathy requiring treatment
Weight changes greater than 11 pounds (5 kg) within the last 3 months before screening
Systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 100 mmHg
End-stage kidney disease
Where to get more information: For more information about this trial or about specific trial locations, please contact Sanofi at [email protected].