Lilly's oral GLP-1, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines, in complete Phase 3 results published in The New England Journal of Medicine
The investigational once-daily pill lowered A1C by an average of 1.3% to 1.6% across doses, with improvements seen as early as four weeks, in adults with type 2 diabetes
In ACHIEVE-1, orforglipron also led to an average weight loss of 16.0 lbs (7.9%) at the highest dose by week 40 in a key secondary endpoint
The safety profile of orforglipron was consistent with the established GLP-1 class
INDIANAPOLIS, June 21, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from ACHIEVE-1, a Phase 3 trial evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Orforglipron is the first oral small molecule (non-peptide) glucagon-like peptide-1 (GLP-1) receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial. At 40 weeks, all three doses (3 mg, 12 mg, 36 mg) of orforglipron achieved the primary endpoint of superior A1C reduction. In addition, the 12 mg and 36 mg doses showed clinically meaningful and statistically significant reductions in body weight vs. placebo. In the study, orforglipron had a safety profile similar to the established GLP-1 class, and the most frequently reported adverse events were gastrointestinal-related. The results were presented at the American Diabetes Association (ADA) 85th Scientific Sessions 2025 and simultaneously published in The New England Journal of Medicine.
In the study, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by 1.3% to 1.6% from a baseline of 8.0%, for the efficacy estimand.1 In key secondary endpoints, up to 76.2% of participants taking orforglipron achieved the ADA treatment target A1C of <7%, 66.0% achieved an A1C of ≤6.5%, and 25.8% achieved <5.7%, defined as a normal A1C value.2,3 Improvements in A1C were observed as early as four weeks and were accompanied by similar reductions in fasting serum glucose. In another key secondary endpoint, participants taking the highest dose of orforglipron lost an average of 16.0 lbs (7.9%). While participants in ACHIEVE-1 did not appear to reach a weight plateau, longer-duration trials, such as the ATTAIN trials, will provide a comprehensive evaluation of the safety and efficacy of orforglipron for the treatment of obesity.
"The ACHIEVE-1 trial demonstrated that orforglipron, a novel oral small-molecule GLP-1, achieved clinically meaningful reductions in A1C and body weight over 40 weeks in adults with type 2 diabetes," said Dr. Julio Rosenstock, senior scientific advisor for Velocity Clinical Research at Medical City Dallas, clinical professor of medicine, University of Texas Southwestern Medical Center, and lead trial investigator. "The early onset of glycemic improvement, observed as soon as four weeks, reinforces the therapeutic potential of orforglipron as an effective, oral GLP-1 therapy for early type 2 diabetes treatment. These findings support further investigation in broader populations and longer-duration studies."
Læs mere: https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-showed-compelling-efficacy-and
The investigational once-daily pill lowered A1C by an average of 1.3% to 1.6% across doses, with improvements seen as early as four weeks, in adults with type 2 diabetes
In ACHIEVE-1, orforglipron also led to an average weight loss of 16.0 lbs (7.9%) at the highest dose by week 40 in a key secondary endpoint
The safety profile of orforglipron was consistent with the established GLP-1 class
INDIANAPOLIS, June 21, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from ACHIEVE-1, a Phase 3 trial evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Orforglipron is the first oral small molecule (non-peptide) glucagon-like peptide-1 (GLP-1) receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial. At 40 weeks, all three doses (3 mg, 12 mg, 36 mg) of orforglipron achieved the primary endpoint of superior A1C reduction. In addition, the 12 mg and 36 mg doses showed clinically meaningful and statistically significant reductions in body weight vs. placebo. In the study, orforglipron had a safety profile similar to the established GLP-1 class, and the most frequently reported adverse events were gastrointestinal-related. The results were presented at the American Diabetes Association (ADA) 85th Scientific Sessions 2025 and simultaneously published in The New England Journal of Medicine.
In the study, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by 1.3% to 1.6% from a baseline of 8.0%, for the efficacy estimand.1 In key secondary endpoints, up to 76.2% of participants taking orforglipron achieved the ADA treatment target A1C of <7%, 66.0% achieved an A1C of ≤6.5%, and 25.8% achieved <5.7%, defined as a normal A1C value.2,3 Improvements in A1C were observed as early as four weeks and were accompanied by similar reductions in fasting serum glucose. In another key secondary endpoint, participants taking the highest dose of orforglipron lost an average of 16.0 lbs (7.9%). While participants in ACHIEVE-1 did not appear to reach a weight plateau, longer-duration trials, such as the ATTAIN trials, will provide a comprehensive evaluation of the safety and efficacy of orforglipron for the treatment of obesity.
"The ACHIEVE-1 trial demonstrated that orforglipron, a novel oral small-molecule GLP-1, achieved clinically meaningful reductions in A1C and body weight over 40 weeks in adults with type 2 diabetes," said Dr. Julio Rosenstock, senior scientific advisor for Velocity Clinical Research at Medical City Dallas, clinical professor of medicine, University of Texas Southwestern Medical Center, and lead trial investigator. "The early onset of glycemic improvement, observed as soon as four weeks, reinforces the therapeutic potential of orforglipron as an effective, oral GLP-1 therapy for early type 2 diabetes treatment. These findings support further investigation in broader populations and longer-duration studies."
Læs mere: https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-showed-compelling-efficacy-and
21/6 2025 17:55 oneofakind 0
126901 Som jeg lige læser dette. Ely oplyser ikke om vægttab, eller bivirkninger, men kun om, at de nu "måske" kan slå Novo mht. dagen hvor pillen ankommer!
21/6 2025 18:03 ProInvestorNEWS 1126902 Du skal klikke dig videre på "Læs mere".
Bivirkningerne er beskrvet flere steder i meddelelsen.
Bemærk at studiet først og fremmest er rettet mod diabetes.
Bivirkningerne er beskrvet flere steder i meddelelsen.
Bemærk at studiet først og fremmest er rettet mod diabetes.
21/6 2025 18:15 ProInvestorNEWS 0126904 Ja...det er diabetes 2. Patientgruppen har diabetes 2 samt overvægt.
21/6 2025 18:20 Helge Larsen/PI-redaktør 3126905 For raske overvægtige mennesker uden type 2-diabetes er der endnu ikke offentliggjort fuldstændige resultater fra fase 3-studier med orforglipron, men Eli Lilly har oplyst, at resultater fra studierne ATTAIN-1 og ATTAIN-2, som evaluerer orforglipron til vægttab hos personer med overvægt eller fedme uden diabetes, forventes i tredje kvartal af 2025. Disse studier er en del af orforgliprons fase 3-program, og yderligere data forventes præsenteret ved American Diabetes Associations 85. kongres og publiceret i peer-reviewede tidsskrifter senere i 2025.
Således er fase 3-studierne for raske overvægtige uden diabetes stadig i gang, med resultater ventet inden udgangen af september 2025.
Således er fase 3-studierne for raske overvægtige uden diabetes stadig i gang, med resultater ventet inden udgangen af september 2025.
21/6 2025 18:41 oneofakind 0126906 Det handler i min optik om at fremstå som "first mover", og igen har Ely stjålet en del af fokus fra de data, Novo pt. præsenterer.. Man må give Ely.. at de timer det godt"
21/6 2025 19:15 Helge Larsen/PI-redaktør 4126907 Stort set alle store og små pharma- og biotkdeltagere på ADA har deres vigtige aktuelle data med. I tilfældet med Eli Lilly og Novo er det helt forventeligt og tilmed tidligere udmeldt hvilke datasæt som de to leverer i disse dage.
PS: Eli Lilly fremtsår ikke som "first mower" med pillen. Det er Novo med Rybelsus i diabetes 2. Ligesom Novo indtil videre er det i vægttabsversionen (Wegowy-pillen) som allerede er indsendt til FDA for endelig godkendelse.
PS: Eli Lilly fremtsår ikke som "first mower" med pillen. Det er Novo med Rybelsus i diabetes 2. Ligesom Novo indtil videre er det i vægttabsversionen (Wegowy-pillen) som allerede er indsendt til FDA for endelig godkendelse.
21/6 2025 20:38 bb8 0126908 Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes
https://www.nejm.org/doi/full/10.1056/NEJMoa2505669
https://www.nejm.org/doi/full/10.1056/NEJMoa2505669
