Sotagliflozin Lowers A1c, Weight Even in Kidney Impairment
"These findings highlight the importance of considering the effect of kidney function to help inform and tailor treatment decision-making for patients with diabetes and CKD," Belinda Hardin, PharmD, senior director of medical communications and head of field medical at Lexicon, said at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2025.
Sotagliflozin, a novel agent that inhibits sodium-glucose cotransporter (SGLT) 1 as well as SGLT2, was approved by the US Food and Drug Administration (FDA) in 2023 for reducing the risks of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in patients with heart failure, and for preventing these same events in patients with type 2 diabetes, CKD, and other cardiovascular disease risk factors.
The drug is not indicated for diabetes. In 2019, the FDA declined to approve sotagliflozin as adjunctive treatment for type 1 diabetes due to concerns about the increased risk for diabetic ketoacidosis. And in 2024, the agency again turned down Lexicon's application for sotagliflozin as a treatment for people with type 1 diabetes and CKD. The company hasn't sought an indication for sotagliflozin for type 2 diabetes.
Two SGLT2 inhibitors, dapagliflozin (Farxiga) and empagliflozin (Jardiance), have indications for preventing heart failure hospitalizations in patients with heart failure as well as approvals for type 2 diabetes and preservation of renal function.
The new findings, from a meta-analysis of eight double-blind, randomized, placebo-controlled trials, suggest that despite the lack of an indication for treatment of diabetes or obesity, sotagliflozin does result in A1c and body weight lowering across all levels of kidney function. This study is a companion to a previous similarly designed analysis showing that the effects of sotagliflozin on systolic blood pressure were maintained in patients with type 2 diabetes regardless of kidney function. Those findings were presented at the American Heart Association Scientific Session 2024, Hardin told Medscape Medical News .
Asked for comment, session moderator Sara E. Lubitz, MD, associate professor of medicine and endocrine program director at Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, told Medscape Medical News : "This opens my mind more that if there is a heart failure patient with diabetes and we're looking for sugar reduction as well as heart failure protection, [sotagliflozin] is probably just as efficacious as the SGLT2 inhibitors...that have the indication for glucose-lowering, but we're not pulling it out as a first-line [treatment]."
All eight trials in the meta-analysis had similar designs and timeframes and were at least 26 weeks in duration. The patient-level intent-to-treat population data were pooled. Patients were divided into three subgroups based on kidney function:
Subgroup 1: estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m 2 (N = 2577)
(N = 2577) Subgroup 2: eGFR ≥ 30 to < 60 mL/min/1.73m 2 (N = 1046)
(N = 1046) Subgroup 3: eGFR < 30 mL/min/1.73m2 (N = 271)
Mean patient ages were 60.2 years in subgroup 1, versus 69.3 and 67.1 years, respectively, in subgroups 2 and 3. The treatment groups were sotagliflozin 400 mg (N = 1728), sotagliflozin 200 mg (N = 728), or placebo (N = 1440).
Overall, compared with placebo, A1c was significantly lowered with 200-mg sotagliflozin (less mean squares [LMS] difference, –0.33) and 400 mg (LMS difference, –0.48). Body weight was also reduced (LMS difference, –1.48 and –1.66, respectively).
The effects on both A1c and body weight of both doses were statistically significant for the overall study population and subgroup 1 (normal kidney function). In subgroup 2, the effect on body weight remained significant for both doses, but only the 400-mg dose effect was significant for lowering A1c.
The 400-mg dose produced significant reductions in all kidney function subgroups for both measures except A1c reduction in subgroup 3, although there was still benefit.
Hardin told Medscape Medical News , "This provides us supplemental information with regard to heart failure outcomes, and not directly focusing on whether there's an additive benefit in terms of A1c or an additive lowering of A1c in patients with chronic kidney disease."
Asked about future plans for sotagliflozin, she replied, "I don't think at this point you'll likely see sotagliflozin before the FDA for a glucose-lowering indication in type 2 patients. The file remains open for type 1 at the FDA, so that work continues."
Hardin is an employee of Lexicon. Lubitz is a speaker for Ascendis and has received clinical trial research funding from Ascendis, Chiasma, and Takeda.
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