The American Diabetes Association (ADA) released the abstracts for its upcoming 74th scientific sessions last Friday, a week ahead of the conference's kickoff in San Francisco.

In their analysis of the abstracts, several analysts highlighted data from the AWARD 6 trial, a head-to-head noninferiority study comparing two GLP-1 targeting drugs: dulaglutide (Eli Lilly and Co.), which is in phase III trials, and approved blockbuster Victoza (liraglutide, Novo Nordisk A/S).

The phase III, randomized, open-label, parallel-arm 26-week AWARD 6 study compared efficacy and safety of 1.5-mg dulaglutide given weekly to 1.8-mg Victoza, given daily in 599 metformin-treated (>/= 1,500 mg) patients with type 2 diabetes.

In terms of glucose control, as measured by hemoglobin A1C, the two groups did the same, which means the trial reached its primary endpoint.

GLP-1 agonists appear to have benefits that go beyond pure glucose control, and a critical one of them is weight loss. According to the World Health Organization, overweight and obesity now causes more deaths globally than malnutrition, and at the recent annual meeting of the American Society of Clinical Oncology, incoming society president Clifford Hudis called obesity "the new tobacco" in terms of its effects on cancer risk.

Both groups in the AWARD 6 trial lost a significant amount of weight. But the weight loss was also significantly greater in patients treated with Victoza than in those receiving dulaglutide. Victoza patients lost an average of almost 8 pounds over the course of the treatment, compared to slightly under 6.5 pounds for the dulaglutide group.

In another recent study, Novo Nordisk reported that obese patients treated with 3 mg of Victoza daily for 13 months lost 8 percent of their body weight, or around 18 pounds. (See BioWorld Today, May 19, 2014.)

ISI group's Mark Schoenebaum concluded that "commercially, the convenience and fewer needle sticks of dulaglutide (administered once weekly vs once daily for liraglutide) will likely appeal to many patients, but the difference in weight loss will likely be a talking point for sales reps visiting doctors' offices. . . . Our initial view is that a 3 kg weight loss reduction for [dulaglutide] is still significant on an absolute basis, and given the 1x weekly regimen, [dulaglutide] should be able to still grab significant share in the GLP-1 market."

In another research note, analysts from Leerink Partners LLC noted that dulaglutide is the first GLP-1 agonist that has been able to show noninferiority to Victoza in a head-to-head comparison of effects on A1C.

The market for GLP-1 targeting drugs is currently around $3 billion a year, and Schoenebaum predicted that given that both volume and price are each increasing at roughly 10 percent annually, it "could easily become a $5-billion plus market" over time, of which he contended dulaglutide could capture up to a third, or $ 1.7 billion.

Others, however, see less, if still considerable, market potential. In February, when the company released initial results of the AWARD 6 trial, Cowen and Co. pegged the 2020 market share of dulaglutide a cool billion dollars lower, at $700 million.

Eli Lilly has submitted new drug applications for weekly dulaglutide to the FDA, the EMA and "other regulatory agencies," according to a company statement.

The drug is currently in more than a dozen phase III trials comparing it to treatments including both other GLP-1 targeting treatments, such as the AWARD 6 trial whose full data will be presented at the conference, and stalwarts like metformin. Lilly will be presenting nine abstracts on the drug at the upcoming meeting.

If it is approved, it will join Amylin Pharmaceuticals Inc.'s once-weekly GLP-1 drug Bydureon (exenatide) and twice-daily Byetta (exenatide, with Eli Lilly and Co.), as well as Victoza.