Research

Principal Investigator: Dr. Stephanie Pointer
Co-Investigators: Dr. Saras Sharma, Mr. Edmond Conway, NP, Ms. Sabrina Briggs, NP
Executive Research Director for Luminal Gastroenterology and Hepatology Clinical Trials: Christina Stanley, CCRC

Gastroenterology Clinical Trials

Please see our active gastroenterology clinical trials below. If you are interested in participating in a study, please contact Mrs. Christina Stanley at gi_research@thegidocs.com

Active and recruiting: Vanda: VP-VLY-686-3301, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy of Tradipitant in Relieving Symptoms of Gastroparesis

https://clinicaltrials.gov/ct2/show/NCT04028492?term=VP-VLY-686-3301&draw=2&rank=1

Active and recruiting: Vanda: VP-VLY-686-3303: SINGLE-PATIENT EXPANDED ACCESS PROTOCOL FOR PRECIPITANTS IN A SINGLE PATIENT WITH GASTROPARESIS

https://clinicaltrials.gov/ct2/show/NCT04474990?term=VP-VLY-686-3303&draw=2&rank=1

Active and recruiting: Braintree Laboratories: BLI500-301 A Phase 3, Double-Blind, Randomized, Two-Phase, Active Controlled Study to Evaluate the Efficacy and Safety of Tegoprazan in Patients With Erosive Esophagitis

Active and recruiting: Braintree Laboratories: BLI500-302 A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tegoprazan in Patients With Non-Erosive Reflux Disease

Active and recruiting: BMS: IM047-029 A Phase 4, Prospective, Open label Study of Ozanimod to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants with Moderate to Severe Ulcerative Colitis in Clinical Practice

https://clinicaltrials.gov/ct2/show/NCT05369832?term=IM047-029&draw=2&rank=1

Active and recruiting: Abbvie: M14-446 A single-arm, open-label study to evaluate the efficacy and safety of ABBV-668 in subjects with moderate to severe ulcerative colitis

On hold: Motus:CL00052 Outpatient Colonoscopy: Demonstration Effective Salvage of Inadequate Colonoscopies Utilizing the Pure-Vu EVS System

https://clinicaltrials.gov/ct2/show/NCT05585879?term=CL00052&draw=2&rank=1

Hepatology Clinical Trials

Please see our active hepatology clinical trials below. If you are interested in participating in a study, please contact Mrs. Christina Stanley at gi_research@thegidocs.com

Closed to enrollment: TERN: TERNCB-2002 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with Presumed Non-Alcoholic Steatohepatitis (NASH)

https://clinicaltrials.gov/ct2/show/NCT05415722

Closed to enrollment: Gilead: GS-US-454-6075 A phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects with Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH)

https://clinicaltrials.gov/ct2/show/NCT04971785?term=Gilead+6075&draw=2&rank=1

Active and recruiting: Novo Nordisk: NN9500-4656: Efficacy and safety investigation of NNC0194-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial

https://clinicaltrials.gov/ct2/show/NCT05016882?term=Novo+4656&draw=2&rank=1

Active and recruiting: Novo Nordisk: NN9931-4553: ESSENCE: The effect of semaglutide in subjects with non-cirrhotic steatohepatitis

ttps://clinicaltrials.gov/ct2/show/NCT04822181?term=Novo+4553&draw=2&rank=1

Active and recruiting: MGL-3196-19 A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients with Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis (MAESTRO-NASH OUTCOMES)

https://clinicaltrials.gov/ct2/show/NCT04951219

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