Eli Lilly’s oral glucagon-like peptide receptor agonist (GLP-1RA) has met the primary and secondary endpoints in a Phase III trial, though its weight loss efficacy lags Novo Nordisk’s oral drug.
In the Phase III ATTAIN-1 trial (NCT05869903), all three doses of once-daily orforglipron delivered statistically and clinically meaningful weight loss of up to 12.4% in the high dose cohort (36mg) after 72 weeks of dosing.
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In addition, the cohort saw that more than half the patients (59.6%) achieved weight loss reductions of over 10% and 39.6% achieved more than a 15% drop in body weight.
A 7.8% weight loss was reported in the low dose (6mg) cohort while in the medium dose (12mg), there was a weight loss of 9.3%. A 0.9% weight loss was seen in the placebo cohort.
The safety profile of orforglipron remained consistent with marketed GLP-1RA’s and most commonly reported adverse events (AEs) were gastrointestinal and generally mild-to-moderate in severity. Discontinuation rates in the low, medium and high doses were 21.9%, 22.5% and 24.4% respectively, compared to 29.9% with placebo.
In April 2025, Lilly said that the Phase III ACHIEVE-1 trial (NCT05971940) of orforglipron in type 2 diabetes (T2D) had met its primary endpoint, reducing A1C levels by an average of 1.3% to 1.6% from a baseline of 8% after 40 weeks.
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By GlobalDataNovo likely to beat Lilly to market
In early 2025, Novo Nordisk said it submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) after its oral 25mg semaglutide demonstrated 13.6% weight loss compared to 2.2% in the placebo cohort after a 64-week dosing period in the OASIS4 trial (NCT05035095).
While this comparison of data does not come from a head-to-head in a study, it is notable that Novo Nordisk’s drug had a higher weight loss, with investors asking about the comparison to Novo Nordisk’s data in the Q2 earnings call on 7 August; however, a Lilly executive stated it is difficult to compare the two trials.
Novo Nordisk expects a decision from the FDA in Q4 2025 for the oral semaglutide, which will be marketed as Wegovy, similar to its subcutaneous version of the drug approved for weight loss.
Oral semaglutide is already available on the market for patients with T2D, under the name Rybelsus, first gaining FDA approval in 2019.
Lilly also confirmed in the 7 August announcement that it will file for review of the oral GLP-1RA with global regulators by the end of 2025. Based on Lilly’s April announcement, submission for the drug in T2D is anticipated in 2026.
As a result of Novo Nordisk’s earlier filing, if approved, it will hold a first-to-market advantage in the oral GLP-1RA obesity field, but Jasper Morley, pharma analyst for GlobalData, said that this will not play out in the long term.
Morley shared: “Novo Nordisk’s oral semaglutide for obesity and Eli Lilly’s orforglipron calcium’s approvals would represent the first oral GLP-1RAs for obesity.
“While both products are expected to launch by 2026, orforglipron calcium is expected to reach blockbuster status first, in 2027, and generate $14.1bn in 2031. Meanwhile, oral semaglutide is expected to reach blockbuster status by 2029 and eventually generate $2.6bn in 2031.”
Eli Lilly and Novo Nordisk rivalry intensifies
Lilly revealed the Phase III ATTAIN-1 data on the same day as the company’s Q2 financials, which showed sales for its subcutaneous GLP-1RA for weight loss, Zepbound (tirzepatide), were $3.38bn, up 172% compared with Q2 2024. Its T2D version of tirzepatide, Mounjaro, also saw its sales rise by 68% compared to the same period in 2024.
Meanwhile, in its H1 and Q2 financials announcement made on 6 August, Novo Nordisk confirmed that sales of its subcutaneous semaglutide products, Wegovy for weight loss and Ozempic for T2D, had increased 16% in H1, compared to a 26% growth for the drugs in H1 2024.
Investors will be keeping an eye on the two companies as they remain the dominant players on the GLP-1RA stage, but there are smaller biotechs and big pharma companies, including Pfizer, that are also hoping to gain a portion of the GLP-1RA market as they develop their pipeline assets.
