Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
YG1699 · 1 trial · 4 indications
To demonstrate that either dose of YG1699 produces a lower area under the concentration-time curve in plasma glucose (AUC(0-120min) ) \[mg/dL\*ml\] expressed as percent of No Treatment mean versus Dapagliflozin after a standardized Mixed Meal Tolerance Test (MMTT), performed on the 6th day of treatment.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | YG1699 10 mg |
| Treatment B | EXPERIMENTAL | YG1699 25 mg |
| Treatment C | ACTIVE_COMPARATOR | Dapagliflozin 10 mg |
| Name | Type | Description |
|---|---|---|
| YG1699 | DRUG | YG1699 is a novel investigational dual inhibitor of sodium-dependent glucose cotransporters, SGLT1 and SGLT2, indicated as an adjunct to diet and exercise to improve glycemic control and weight loss in adults with T2DM. A subsequent indication will be developed for YG1699 to improve glycemic control in adults with T1DM. The proposed dosage form is a yellow, film-coated tablet for oral administration. The proposed tablet strengths for the current clinical research are 5 mg and 25 mg. The tablets are packaged in high-density polyethylene (HDPE) bottles with HDPE caps and desiccant inserters. Each HDPE bottle contains 30 tablets of drug product. The study drug YG1699 is manufactured by Youngene Therapeutics Inc., Ltd., China. |
| Dapagliflozin | DRUG | Farxiga® is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. Faxiga® is available as a film-coated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol and the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, crospovidone, silicon dioxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide. |
Inclusion Criteria: 1. Subjects ≥ 18 to ≤ 60 years of age at the time of signing the informed consent. 2. Subjects diagnosed with T1DM for ≥ 12 months. 3. Subjects who are currently using an approved insulin pump, with a stable basal insulin dose. Stable is defined as \< 20% change of dose during t...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
YG1699 is an investigational small molecule being developed for diabetes. It was studied in a Phase 2 crossover trial in subjects with type 1 diabetes, where researchers compared postprandial glucose after a mixed meal tolerance test and evaluated the metabolic effects of insulin withdrawal. The trial enrolled 19 participants in the United States.
The molecular target of YG1699 has not been disclosed. The drug is a small molecule in development for diabetes, and the completed Phase 2 trial focused on glucose response and insulin withdrawal effects in type 1 diabetes, but no specific target has been publicly identified.
YG1699 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker YCBD. The company is advancing the drug as an investigational small molecule for diabetes, with clinical development conducted in the United States.
YG1699 is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed for the drug. The drug remains investigational and has not been approved by the FDA.
YG1699 has one completed Phase 2 clinical trial, registered as NCT04956263. The study, titled "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," enrolled 19 participants in the United States. The trial was randomized, double-blind, and active-controlled.
No alternative names for YG1699 have been disclosed. The drug is identified solely as YG1699 in clinical trial records, and no other names or aliases have been publicly associated with this investigational small molecule for diabetes.