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P-III trial of survodutide (3.6 or 6mg, QW) in 755 pts, met both co-1EP using treatment-regimen & efficacy estimands. At Wk. 76, weight loss reached up to an average of 13.1% vs 3.1% with PBO, while up to 79.3% vs 32.7% pts achieved ≥5% weight loss (efficacy estimand)
In 2EPs, trial showed reduced HbA1c…
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TRIUMPH-2 assessed retatrutide (4, 9, or 12mg, QW) vs PBO in 1152 pts with T2D & obesity/overweight, with trial using a stepwise dose-escalation approach at Q4W. Lilly plans to file BLA in Q1’27
At 80wks., avg. body weight reductions were 12.7% (4mg), 19.1% (9mg), & 20.8% (12mg) vs 4%, plus A1C reduced by 1.4%,…
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Nanexa has entered into a global exclusive license & collaboration agreement with Novo for the use of its PharmaShell ALD drug delivery technology platform, for certain peptide-based drugs targeting obesity, T2D & other cardiometabolic indications
As per the deal, Novo will receive a global license to Nanexa’s PharmaShell platform for use in ~5 development programs,…
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The US FDA has approved Onswik (insulin efsitora alfa-gobe) along with diet and exercise to control high blood sugar in adults with type 2 diabetes
Approval was based on the P-III (QWINT) trials, which evaluated Onswik (QW) in >3,400 adults with T2D; across each trial, Onswik met the 1EP, demonstrating non-inferior A1C reductions vs…
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China’s NMPA has accepted marketing registration application for insulin degludec & liraglutide injection (IDegLira), developed by TUL’s wholly owned subsidiary Zhuhai United Bio-Pharmaceutical
IDegLira is a once-daily fixed-dose combination of basal insulin degludec and the GLP-1 analogue liraglutide for type 2 diabetes, designed to provide complementary glucose-lowering effects while simplifying treatment
Through complementary and…
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TRIUMPH-2 assessed retatrutide (4, 9, or 12mg, QW) vs PBO in 1152 pts with T2D & obesity/overweight, while TRIUMPH-3 assessed retatrutide (9 or 12mg, QW) in 1949 pts with severe obesity & CV disease; trials used a stepwise dose-escalation approach at Q4W
In TRIUMPH-3, 12mg reduced TGs, non-HDL cholesterol, systolic BP, waist circumference, &…
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Insulet has enrolled the first patient in its EVOLVE study to evaluate safety & efficacy of its fully closed-loop (FCL) Omnipod M System, an automated insulin delivery system for T2D vs standard therapy
Trial will assess the system in ~350 T2D pts (18-75yrs.) using insulin (basal-bolus or basal-only), across the US, with prior feasibility data (presented…
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Novo Nordisk has reported the P-IIIa (PIONEER TEENS) trial assessing oral semaglutide (3, 7 or 14mg, QD) vs PBO, on top of background treatment with metformin, basal insulin, or both, in 132 pts (10-17yrs.) with type 2 diabetes
Trial showed superior HbA1c reduction vs PBO, lowering blood sugar by 0.83% at 26wks., with a…
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Eli Lilly reported positive topline results from the P-III (ACHIEVE-4) study of Foundayo (orforglipron) vs insulin glargine in ~2,700 pts with type 2 diabetes, and obesity or overweight with elevated CV risk, meeting the 1EP of non-inferiority in MACE-4 events
Foundayo demonstrated a 16% lower risk of MACE-4 and 23% lower risk of MACE-3,…
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The US FDA approved Awiqli (insulin icodec-abae; 700 units/mL) to improve glycaemic control in adults with type 2 diabetes as an adjunct to diet & exercise, with Novo planning a US launch in the FlexTouch device in H2’26
Approval was based on the P-IIIa (ONWARDS) program assessing Awiqli (QW) vs basal insulin (QD) in…

