S-309309
/ Shionogi
- LARVOL DELTA
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January 21, 2025
Safety, Tolerability, and Pharmacokinetics of a Novel Anti-obesity Agent, S-309309, in Healthy Adults with or Without Obesity.
(PubMed, Clin Drug Investig)
- P1 | "S-309309 was well tolerated as single-dose (up to 300 mg) and multiple-dose (50 mg once daily for 14 days) oral administration. The pharmacokinetic characteristics remained unaffected by obesity and food intake. S-309309 did not affect the pharmacokinetics of the cytochrome P450 3A substrate. Overall, S-309309 had an acceptable safety profile and favorable pharmacokinetic and pharmacodynamic characteristics."
Clinical • Journal • PK/PD data • Genetic Disorders • Obesity
September 27, 2024
S-309309, a MGAT2 Inhibitor, Enhances the Weight-Loss Effect of Semaglutide in DIO Mice
(OBESITY WEEK 2024)
- "Our results suggest that when combined with semaglutide, S-309309 synergistically enhances the weight-loss effect and have no impact on gastrointestinal adverse events assessed with saccharin preference test. The combination therapy of S-309309 with semaglutide holds promise as weight-loss strategy."
Preclinical • Gastrointestinal Disorder • Genetic Disorders • Obesity
October 21, 2024
Simultaneous Overcoming Approach for Poor Wettability and Low Stability in Stomach by Simple Methods; Formulation Design and Development of Monoacylglycerol Acyltransferase 2 Inhibitor, S-309309.
(PubMed, Chem Pharm Bull (Tokyo))
- "In addition, by encapsulating S-309309, the increase of degradation product amount was suppressed under acidic conditions, suggesting that the suppression of degradation product formation would be expected in the stomach after oral dosing. Overall, these results suggest that the drug property issues of S-309309 can be overcome by mixing S-309309 with a water-soluble polymer and encapsulation."
Journal • Genetic Disorders • Obesity
July 28, 2024
The Continuous and Reversible Transformation of the Polymorphs of an MGAT2 Inhibitor (S-309309) from the Anhydrate to the Hydrate in Response to Relative Humidity.
(PubMed, Pharmaceutics)
- "A mechanism for the reversible crystal transformation between the anhydrate and pseudo-polymorphs of the hydrate was discovered. We concluded that S-309309 causes a pseudo-polymorphic transformation; however, this is not a critical issue for pharmaceutical use."
Journal
June 28, 2024
Safety and Efficacy Study of S-309309 in Obese Adults
(clinicaltrials.gov)
- P2 | N=365 | Completed | Sponsor: Shionogi | Active, not recruiting ➔ Completed
Trial completion • Genetic Disorders • Obesity
May 21, 2024
S-309309, a Novel MGAT2 Inhibitor, Enhances Intestinal Fatty Acid Beta Oxidation and Provides Metabolic Benefits in DIO Mice
(ADA 2024)
- "S-309309 enhanced beta oxidation in the intestine and increased energy expenditure in DIO mice. Also, S-309309 improved insulin sensitivity and fatty liver. Taken together, these results suggest that S-309309 may be a promising anti-obesity drug that improves metabolism with multiple mechanisms of action."
Preclinical • Metabolic Disorders • Obesity
February 29, 2024
Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants
(clinicaltrials.gov)
- P1 | N=14 | Completed | Sponsor: Shionogi | Active, not recruiting ➔ Completed
Trial completion • Genetic Disorders • Obesity
January 17, 2024
Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants
(clinicaltrials.gov)
- P1 | N=14 | Active, not recruiting | Sponsor: Shionogi | Recruiting ➔ Active, not recruiting
Enrollment closed • Genetic Disorders • Obesity
October 31, 2023
Safety and Efficacy Study of S-309309 in Obese Adults
(clinicaltrials.gov)
- P2 | N=365 | Active, not recruiting | Sponsor: Shionogi | Recruiting ➔ Active, not recruiting
Enrollment closed • Genetic Disorders • Obesity • CRP • LEP
October 31, 2023
Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants
(clinicaltrials.gov)
- P1 | N=14 | Recruiting | Sponsor: Shionogi | Not yet recruiting ➔ Recruiting
Enrollment open • Genetic Disorders • Obesity
October 30, 2023
Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants
(clinicaltrials.gov)
- P1 | N=14 | Not yet recruiting | Sponsor: Shionogi
New P1 trial • Genetic Disorders • Obesity
July 03, 2023
Safety and Efficacy Study of S-309309 in Obese Adults
(clinicaltrials.gov)
- P2 | N=320 | Recruiting | Sponsor: Shionogi | Not yet recruiting ➔ Recruiting
Enrollment open • Genetic Disorders • Obesity • CRP • LEP
June 29, 2023
Safety and Efficacy Study of S-309309 in Obese Adults
(clinicaltrials.gov)
- P2 | N=320 | Not yet recruiting | Sponsor: Shionogi
New P2 trial • Genetic Disorders • Obesity • CRP • LEP
November 07, 2022
A Study to Assess S-309309 in Healthy and Obese Participants
(clinicaltrials.gov)
- P1 | N=74 | Completed | Sponsor: Shionogi | Recruiting ➔ Completed
Trial completion • Genetic Disorders • Obesity
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