PATHFNDR-1
Research type
Research Study
Full title
A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with Acromegaly Treated with Long-acting Somatostatin Receptor Ligands
IRAS ID
299780
Contact name
William Drake
Contact email
Sponsor organisation
Crinetics Pharmaceuticals, Inc.
Eudract number
2020-005431-70
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
137912, IND
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
This is a multicenter, multinational study which will recruit approximately 52 patients with acromegaly and who have been treated with long-acting somatostatin receptor ligands (SRL) This study will investigate the safety and efficacy of paltusotine, taken orally.
These study participants will enter a screening phase first of up to 12 weeks, consisting of up to 3 study visits.
If a participant is eligible to take part after this screening period, they will be enrolled at random (via an interactive web-based system) with a 50/50 chance to receive either paltusotine or placebo. This is the treatment phase with about 11 study visits and lasting approximately 36 weeks.
At the end of the treatment phase, if the Investigator thinks the participant will benefit from treatment with paltustotine, the participant may roll over into a 96 week treatment period with paltusotine. Everyone will receive paltustione in this open-label extension phase.Participants will receive their last SRL injection (ocreotide or lanreotide) during screening. Paltusotine will be received at the time the next SRL dose would have been due.
Participants will undergo investigations such as an MRI scan of the pituitary, ultrasound of the gallbladder, and ECGs.
Blood will be sampled to determine safety laboratory results, growth hormone levels, pharmacokinetic information and if consented to, a genotype blood sample (participants' genetic material determines how they will respond to the treatment).
Some blood samples for growth hormone determination, will be performed under fasting conditions.
Individual participation in the study can last from 2.5 to 3 years in total.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
21/EM/0165
Date of REC Opinion
12 Aug 2021
REC opinion
Further Information Favourable Opinion