YG1699 / Youngene Therap - LARVOL DELTA

PK and PD of YG1699 in CKD Patients With Diabetes (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: RenJi Hospital

New P1 trial • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease

A Randomized Crossover Trial of Mixed Meal Tolerance Test Response in People with Type 1 Diabetes on Insulin Pump Therapy and YG1699 or Dapagliflozin. (PubMed, Clin Pharmacol Ther) - "YG1699 reduced post-prandial glucose more than dapagliflozin in people with T1D on insulin pump therapy. The results were consistent with dual SGLT1/SGLT2 inhibition by YG1699."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Effects of YG1699 and Sotagliflozin on Blood Glucose and Urinary Glucose Excretion in SD Rats (ADA 2023) - "Background and Aims: YG1699, a dual inhibitor of SGLT1 and SGLT2, recently showed greater glucose lowering than dapagliflozin in patients with type 1 diabetes. Significant reductions in post-prandial glucose with YG1699 and sotagliflozin are associated with increased UGE. Glucose AUC after 10mg/kg YG1699 was less than 50% of vehicle."

Preclinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Effects of YG1699 and Sotagliflozin on Intestinal Glucose Absorption and GLP-1 in Mice (ADA 2023) - "Background and Aims: YG1699, a dual inhibitor of SGLT1 and SGLT2, recently showed greater glucose reduction than dapagliflozin in patients with type 1 diabetes. YG1699 delays intestinal glucose absorption and induces an incretin response in BALB/c mice, indicating significant gastrointestinal SGLT1 inhibition."

Preclinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

To Evaluate the Safety, Tolerability, and Pharmacokinetics of YG1699（Antidiabetic） in Healthy Chinese Sbjects (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: Youngene Therapeutics Inc., Ltd. | Recruiting ➔ Completed | N=20 ➔ 31 | Trial completion date: May 2022 ➔ Aug 2022 | Trial primary completion date: Mar 2022 ➔ Aug 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders

Post-prandial glucose reduction with YG1699 compared to dapagliflozin in subjects with type 1 diabetes (EASD 2022) - P2 | "YG1699 reduced post-prandial glucose significantly more than dapagliflozin in subjects with T1D and was well-tolerated in this study. The pattern of lower post-prandial glucose, a greater GLP-1 response, and similar urinary glucose excretion compared to dapagliflozin in the MMTT indicate that YG1699 provided dual inhibition of SGLT1 and SGLT2."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

A Comparison of Postprandial Glucose After a MMTT, and the Metabolic Effects of Insulin Withdrawal in a Crossover Study in Subjects With Type 1 Diabetes (clinicaltrials.gov) - P2 | N=19 | Completed | Sponsor: Youngene Therapeutics Inc., Ltd. | Recruiting ➔ Completed | Trial primary completion date: Jul 2022 ➔ Feb 2022

Trial completion • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Comparison of Postprandial Glucose After a MMTT, and the Metabolic Effects of Insulin Withdrawal in a Crossover Study in Subjects With Type 1 Diabetes (clinicaltrials.gov) - P2 | N=18 | Recruiting | Sponsor: Youngene Therapeutics Inc., Ltd. | Trial completion date: Apr 2022 ➔ Jul 2022 | Trial primary completion date: Apr 2022 ➔ Jul 2022

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Comparison of Postprandial Glucose After a MMTT, and the Metabolic Effects of Insulin Withdrawal in a Crossover Study in Subjects With Type 1 Diabetes (clinicaltrials.gov) - P2 | N=18 | Recruiting | Sponsor: Youngene Therapeutics Inc., Ltd. | Trial primary completion date: Dec 2021 ➔ Apr 2022

Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

To Evaluate the Safety, Tolerability, and Pharmacokinetics of YG1699（Antidiabetic） in Healthy Chinese Sbjects (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Youngene Therapeutics Inc., Ltd.; Not yet recruiting ➔ Recruiting; Trial primary completion date: Dec 2021 ➔ Mar 2022

Enrollment open • Trial primary completion date • Diabetes • Metabolic Disorders

To Evaluate the Safety, Tolerability, and Pharmacokinetics of YG1699（Antidiabetic） in Healthy Chinese Sbjects (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Youngene Therapeutics Inc., Ltd.

Clinical • New P1 trial • Diabetes • Metabolic Disorders

[VIRTUAL] Yg1699, a novel dual systemic SGLT1 and SGLT2 inhibitor, decreases blood glucose and improves kidney function in primates with diabetic kidney disease (EASD 2021) - "These results are consistent with the mechanism of action of the dual systemic SGLT1 and SGLT2 inhibitor YG1699 and are supportive of a potential for renoprotection in this NHP model of T2D with DKD."

Metabolic Disorders • Obesity

A Comparison of Postprandial Glucose After a MMTT, and the Metabolic Effects of Insulin Withdrawal in a Crossover Study in Subjects With Type 1 Diabetes (clinicaltrials.gov) - P2; N=18; Recruiting; Sponsor: Youngene Therapeutics Inc., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Comparison of Postprandial Glucose After a MMTT, and the Metabolic Effects of Insulin Withdrawal in a Crossover Study in Subjects With Type 1 Diabetes (clinicaltrials.gov) - P2; N=18; Not yet recruiting; Sponsor: Youngene Therapeutics Inc., Ltd.

Clinical • New P2 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses of YG1699 (clinicaltrials.gov) - P1; N=64; Completed; Sponsor: Youngene Therapeutics Inc., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion

[VIRTUAL] First-in-Human Study of YG1699, an SGLT1 and SGLT2 Dual Transporter Inhibitor (ADA 2020) - P1 | "The data also show that YG1699 has adequate half-life that can support once daily dosing in Phase II clinical trials. Adverse events were low and generally mild and no SAEs were observed."

Late-breaking abstract • P1 data • Metabolic Disorders

A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses of YG1699 (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: Youngene Therapeutics Inc., Ltd.; Completed ➔ Recruiting; Trial completion date: Nov 2019 ➔ Jun 2020; Trial primary completion date: Nov 2019 ➔ Apr 2020

Clinical • Enrollment open • Trial completion date • Trial primary completion date

A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses of YG1699 (clinicaltrials.gov) - P1; N=64; Completed; Sponsor: Youngene Therapeutics Inc., Ltd.; Recruiting ➔ Completed; Trial completion date: Feb 2020 ➔ Nov 2019

Trial completion • Trial completion date