CLINICAL TRIALS PROFILE FOR PALTUSOTINE

Clinical Trials for Paltusotine

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03789656 ↗	An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)	Completed	Crinetics Pharmaceuticals Inc.	Phase 2	An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.
NCT03792555 ↗	A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)	Completed	Crinetics Pharmaceuticals Inc.	Phase 2	A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are responders to octreotide LAR or lanreotide depot.
NCT04261712 ↗	A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)	Enrolling by invitation	Crinetics Pharmaceuticals Inc.	Phase 2	A phase 2, open label, long-term extension study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly.
NCT04837040 ↗	A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly	Recruiting	Crinetics Pharmaceuticals Inc.	Phase 3	A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.
NCT05192382 ↗	A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)	Recruiting	Crinetics Pharmaceuticals Inc.	Phase 3	A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.
NCT05361668 ↗	Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome	Recruiting	Crinetics Pharmaceuticals Inc.	Phase 2	The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase.

Clinical Trial Conditions for Paltusotine

Condition Name

Condition Name
Intervention	Trials
Acromegaly	5
Carcinoid Intestine Tumor	1
Carcinoid Syndrome	1
Carcinoid Syndrome Diarrhea	1

Condition MeSH

Condition MeSH
Intervention	Trials
Acromegaly	5
Diarrhea	1
Carcinoid Tumor	1
Syndrome	1

Clinical Trial Locations for Paltusotine

Trials by Country

Trials by Country
Location	Trials
United States	31
Brazil	4
Romania	3
United Kingdom	3
Hungary	3

Trials by US State

Trials by US State
Location	Trials
California	5
Pennsylvania	4
Texas	3
Oregon	3
Ohio	3

Clinical Trial Progress for Paltusotine

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	4

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	3
Completed	2
Enrolling by invitation	1

Clinical Trial Sponsors for Paltusotine

Sponsor Name

Sponsor Name
Sponsor	Trials
Crinetics Pharmaceuticals Inc.	6

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	6