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Cited by 81Diabetes Treatment and ManagementPharmacology and Obesity TreatmentBariatric Surgery and Outcomes

The effects of licogliflozin, a dual SGLT1/2 inhibitor, on body weight in obese patients with or without diabetes

He, Yan‐Ling, Haynes, William, Meyers, Charles D., Amer, Ahmed, Zhang, Yiming, Mahling, Ping, Mendonza, Anisha E., Ma, Shenglin +2 more·2019·Diabetes, Obesity and Metabolism
DOI 10.1111/dom.13654
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Abstract

BACKGROUND There is an unmet need for a safer and more effective treatment for obesity. This study assessed the effects of licogliflozin, a dual inhibitor of sodium‐glucose co‐transporter (SGLT) 1/2, on body weight, metabolic parameters and incretin hormones in patients with type 2 diabetes mellitus (T2DM) and/or obesity. METHODS Patients with obesity (BMI, 35‐50 kg/m 2 ) were enrolled into a 12‐week study (N = 88; licogliflozin 150 mg q.d.). Patients with T2DM were enrolled into a second, two‐part study, comprising a single‐dose cross‐over study (N = 12; 2.5 − 300 mg) and a 14‐day dosing study (N = 30; 15 mg q.d). Primary endpoints included effects on body weight, effects on glucose, safety and tolerability. Secondary endpoints included urinary glucose excretion (UGE 24 ) and pharmacokinetics, while exploratory endpoints assessed the effects on incretin hormones (total GLP‐1, PYY 3‐36 , and GIP), insulin and glucagon. RESULTS Treatment with licogliflozin 150 mg q.d. for 12 weeks in patients with obesity significantly reduced body weight by 5.7% vs placebo ( P < 0.001) and improved metabolic parameters such as significantly reduced postprandial glucose excursion (21%; P < 0.001), reduced insulin levels (80%; P < 0.001) and increased glucagon (59%; P < 0.001). In patients with T2DM, a single dose of licogliflozin 300 mg in the morning prior to an oral glucose tolerance test (OGTT) remarkably reduced glucose excursion by 93% ( P < 0.001; incremental AUC 0‐4h ) and suppressed insulin by 90% ( P < 0.01; incremental AUC 0‐4h ). Treatment with licogliflozin 15 mg q.d. for 14 days reduced 24‐hour average glucose levels by 26% (41 mg/dL; P < 0.001) and increased UGE 24 to 100 g ( P < 0.001) in patients with T2DM. In addition, this treatment regimen significantly increased total GLP‐1 by 54% ( P < 0.001) and PYY 3‐36 by 67% ( P < 0.05) post OGTT vs placebo, while significantly reducing GIP levels by 53% ( P < 0.001). Treatment with licogliflozin was generally safe and well tolerated. Diarrhea (increased numbers of loose stool) was the most common adverse event in all studies (90% with licogliflozin vs 25% with placebo in the 12‐week study), while a lower incidence of flatulence, abdominal pain and abdominal distension (25%‐43% with licogliflozin vs 9%‐11% with placebo in the 12‐week study) were among the other gastrointestinal events reported. CONCLUSION Licogliflozin treatment (1‐84 days) leads to significant weight loss and favourable changes in a variety of metabolic parameters and incretin hormones. Dual inhibition of SGLT1/2 with licogliflozin in the gut and kidneys is an attractive strategy for treating obesity and diabetes.

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  • Diarrhea occurred in 90% of those who received licogliflozin.

    “Diarrhea occurred in 90% who received licogliflozin [107, 108].”

    From Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? (2021) · cites this paper as [107]

  • Recent RCTs demonstrated that licogliflozin, a dual SGLT1/2 inhibitor, significantly reduced body weight by 5.7% over 12 weeks and 3.8% over 24 weeks in obese patients (BMI 35-50 kg/m2) with or without diabetes.

    “Recent RCTs demonstrated that licogliflozin, a dual SGLT1/2 inhibitor, significantly reduced body weight by 5.7% over 12 weeks and 3.8% over 24 weeks in obese patients (BMI, 35–50 kg/m2) with or without diabetes.”

    From Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? (2021) · cites this paper as [107]

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Authors
He, Y., Haynes, W., Meyers, C. D., Amer, A., Zhang, Y., Mahling, P., Mendonza, A. E., Ma, S., Chutkow, W., & Bachman, E.
Affiliations
  • Translational Medicine, Novartis Institutes for BioMedical Research Cambridge Massachusetts
  • Novartis (United States) (US)
  • Novartis Institutes for BioMedical Research (CH)
  • Cardiovascular and Metabolism Disease Area, Novartis Institutes for BioMedical Research Cambridge Massachussets
  • Vertex Pharmaceuticals (United States) (US)
ORCID
Venue
Diabetes, Obesity and Metabolism
Publisher
Wiley
Published
2019-03-15
Volume
21
Issue
6
Pages
1311-1321
ISSN
  • 1462-8902 (ISSN-L)
  • 1463-1326
DOI
10.1111/dom.13654
OpenAlex
W2914630168
Cited by
81
References
48
Citations by year
2026: 3 · 2025: 7 · 2024: 11 · 2023: 8 · 2022: 13 · 2021: 15 · 2020: 17 · 2019: 6
FWCI
10.55
Type
journal article
Language
en
Open access
closed
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • Diabetes Obesity and Metabolism (publishedVersion)
  • PubMed (publishedVersion)
Funders
Novartis Institutes for BioMedical Research
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
  • Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
Keywords
obesity, type 2 diabetes, weight loss, postprandial blood glucose, insulin suppression, glucagon, incretins, glucagon-like peptide-1, PYY3-36, glucose-dependent insulinotropic polypeptide, urinary glucose excretion, pharmacokinetics, drug safety and tolerability, antidiabetic therapy
MeSH terms
Sodium-Glucose Transporter 2 Inhibitors, Adult, Anhydrides, Blood Glucose, Body Weight, Diabetes Mellitus, Type 2, Female, Humans, Male, Middle Aged, Obesity, Sorbitol, Cross-Over Studies, Young Adult

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