Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2) (NCT NCT05192382)
NCT ID: NCT05192382
Last Updated: 2026-05-15
Results Overview
A value \>1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level ≤1.0×ULN based on the average of last 2 measurements.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
111 participants
Primary outcome timeframe
Week 24
Results posted on
2026-05-15
Participant Flow
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study where a total of 209 participants were screened, of which 111 participants were randomized (54 participants in the total paltusotine group and 57 participants in the placebo group) to the randomized control (RC) phase.
Participants were randomized 1:1 to paltusotine or placebo in the RC phase, stratified by prior treatment (medically naive or previously treated versus washout). Those who completed RC or met rescue criteria entered the open-label extension (OLE). The RC phase is complete; the OLE is ongoing.
Participant milestones
| Measure |
RC: Paltusotine Then OLE
Participants were randomized in a 1:1 ratio and received a daily dose of paltusotine orally.
|
RC: Placebo Then OLE
Participants were randomized to receive matching placebo tablets in a 1:1 ratio.
|
Direct to OLE: Paltusotine
At the completion of study enrollment, participants who met eligibility criteria were directly enrolled in the OLE. The OLE is paltusotine only.
|
|---|---|---|---|
|
RC Phase (Up to Week 24)
STARTED
|
54
|
57
|
0
|
|
RC Phase (Up to Week 24)
COMPLETED
|
52
|
54
|
0
|
|
RC Phase (Up to Week 24)
NOT COMPLETED
|
2
|
3
|
0
|
|
OLE Phase (Up to Week 200)
STARTED
|
50
|
52
|
11
|
|
OLE Phase (Up to Week 200)
Ongoing
|
49
|
48
|
10
|
|
OLE Phase (Up to Week 200)
COMPLETED
|
0
|
0
|
0
|
|
OLE Phase (Up to Week 200)
NOT COMPLETED
|
50
|
52
|
11
|
Reasons for withdrawal
| Measure |
RC: Paltusotine Then OLE
Participants were randomized in a 1:1 ratio and received a daily dose of paltusotine orally.
|
RC: Placebo Then OLE
Participants were randomized to receive matching placebo tablets in a 1:1 ratio.
|
Direct to OLE: Paltusotine
At the completion of study enrollment, participants who met eligibility criteria were directly enrolled in the OLE. The OLE is paltusotine only.
|
|---|---|---|---|
|
RC Phase (Up to Week 24)
Adverse Event
|
1
|
1
|
0
|
|
RC Phase (Up to Week 24)
Withdrawal by Subject
|
1
|
2
|
0
|
|
OLE Phase (Up to Week 200)
Discontinued
|
1
|
4
|
1
|
|
OLE Phase (Up to Week 200)
Ongoing
|
49
|
48
|
10
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)
Baseline characteristics by cohort
| Measure |
Direct to OLE: Paltusotine
n=11 Participants
At the completion of study enrollment, participants who met eligibility criteria were directly enrolled in the OLE. The OLE is paltusotine only.
|
Total
n=122 Participants
Total of all reporting groups
|
Paltusotine
n=54 Participants
Participants were randomized in a 1:1 ratio and received a daily dose of paltusotine orally.
|
Placebo
n=57 Participants
Participants were randomized to receive matching placebo tablets in a 1:1 ratio.
|
|---|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 8.59 • n=20 Participants
|
50.6 years
STANDARD_DEVIATION 11.49 • n=186 Participants
|
47.5 years
STANDARD_DEVIATION 13.59 • n=11 Participants
|
45.9 years
STANDARD_DEVIATION 12.30 • n=9 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
63 Participants
n=186 Participants
|
26 Participants
n=11 Participants
|
33 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=20 Participants
|
59 Participants
n=186 Participants
|
28 Participants
n=11 Participants
|
24 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=20 Participants
|
42 Participants
n=186 Participants
|
18 Participants
n=11 Participants
|
18 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=20 Participants
|
72 Participants
n=186 Participants
|
31 Participants
n=11 Participants
|
36 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
8 Participants
n=186 Participants
|
5 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
35 Participants
n=186 Participants
|
15 Participants
n=11 Participants
|
19 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=20 Participants
|
7 Participants
n=186 Participants
|
2 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=20 Participants
|
62 Participants
n=186 Participants
|
28 Participants
n=11 Participants
|
30 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=20 Participants
|
12 Participants
n=186 Participants
|
6 Participants
n=11 Participants
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
6 Participants
n=186 Participants
|
3 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full Analysis Set
A value \>1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level ≤1.0×ULN based on the average of last 2 measurements.
Outcome measures
| Measure |
Paltusotine
n=54 Participants
Participants were randomized in a 1:1 ratio and received a daily dose of paltusotine orally.
|
Placebo
n=57 Participants
Participants were randomized to receive matching placebo tablets in a 1:1 ratio.
|
|---|---|---|
|
Percentage of Participants With a Biochemical Response in Insulin-like Growth Factor-1 (IGF-1) at the End of the Randomized Control Phase (EOR)
|
55.6 percentage of participants
|
5.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Full Analysis Set
A value \>1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Baseline was defined as the last non-missing assessment prior to first dose of study drug for all assessments except IGF-1, growth hormone (GH), and acromegaly symptoms diary (ASD). Change from Baseline was determined by calculating (post-Baseline value - Baseline value).
Outcome measures
| Measure |
Paltusotine
n=54 Participants
Participants were randomized in a 1:1 ratio and received a daily dose of paltusotine orally.
|
Placebo
n=57 Participants
Participants were randomized to receive matching placebo tablets in a 1:1 ratio.
|
|---|---|---|
|
Change in IGF-1 From Baseline to EOT
|
-0.819 nanograms per milliliter (ng/ml)
Standard Error 0.0789
|
0.087 nanograms per milliliter (ng/ml)
Standard Error 0.0751
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Full Analysis Set
A value \>1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level \<1.3×ULN based on the average of last 2 measurements.
Outcome measures
| Measure |
Paltusotine
n=54 Participants
Participants were randomized in a 1:1 ratio and received a daily dose of paltusotine orally.
|
Placebo
n=57 Participants
Participants were randomized to receive matching placebo tablets in a 1:1 ratio.
|
|---|---|---|
|
Percentage of Participants Achieving IGF-1 <1.3×ULN at EOR
|
66.7 percentage of participants
|
14 percentage of participants
|
SECONDARY outcome
Timeframe: Week 22Population: Full Analysis Set
The average from integrated GH sampling at week 22 was used to determine response.
Outcome measures
| Measure |
Paltusotine
n=54 Participants
Participants were randomized in a 1:1 ratio and received a daily dose of paltusotine orally.
|
Placebo
n=57 Participants
Participants were randomized to receive matching placebo tablets in a 1:1 ratio.
|
|---|---|---|
|
Percentage of Participants With Growth Hormone (GH) Concentration <1 ng/mL at Week 22
|
57.4 percentage of participants
|
17.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Full Analysis Set
The ASD is a sponsor-developed daily diary to assess important acromegaly symptoms from the patient perspective. The weekly average ASD total score is calculated from 7 items associated with acromegaly (headache pain, joint pain, sweating, fatigue, weakness in legs, swelling, and numbness or tingling). The ASD total score ranges from 0 to 70 with each symptom contributing up to 10 points. A higher score = higher symptom severity. Change from baseline in total ASD was defined as the postbaseline total ASD score (the average of the available scores seven days on or prior to the scheduled visit date) minus the baseline total ASD score.
Outcome measures
| Measure |
Paltusotine
n=54 Participants
Participants were randomized in a 1:1 ratio and received a daily dose of paltusotine orally.
|
Placebo
n=57 Participants
Participants were randomized to receive matching placebo tablets in a 1:1 ratio.
|
|---|---|---|
|
Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOT
|
-2.669 units on a scale
Standard Error 1.4221
|
2.754 units on a scale
Standard Error 1.3641
|
Adverse Events
Paltusotine
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
Direct to OLE: Paltusotine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paltusotine
n=54 participants at risk
Participants were randomized in a 1:1 ratio and received a daily titrated dose of paltusotine orally.
|
Placebo
n=57 participants at risk
Participants were randomized to receive matching placebo tablets in a 1:1 ratio.
|
Direct to OLE: Paltusotine
n=11 participants at risk
At the completion of study enrollment, participants who met eligibility criteria were directly enrolled in the OLE. The OLE is paltusotine only.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
1.8%
1/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
Other adverse events
| Measure |
Paltusotine
n=54 participants at risk
Participants were randomized in a 1:1 ratio and received a daily titrated dose of paltusotine orally.
|
Placebo
n=57 participants at risk
Participants were randomized to receive matching placebo tablets in a 1:1 ratio.
|
Direct to OLE: Paltusotine
n=11 participants at risk
At the completion of study enrollment, participants who met eligibility criteria were directly enrolled in the OLE. The OLE is paltusotine only.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
18/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
17.5%
10/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
9.1%
1/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
3/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
10.5%
6/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
6/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
3.5%
2/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Gastrointestinal disorders
Nausea
|
9.3%
5/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
3.5%
2/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.3%
5/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
1.8%
1/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.7%
2/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
5.3%
3/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
4/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
17.5%
10/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
3/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
7.0%
4/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Infections and infestations
Sinusitis
|
1.9%
1/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
7.0%
4/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Nervous system disorders
Headache
|
20.4%
11/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
33.3%
19/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
9.1%
1/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Nervous system disorders
Paraesthesia
|
9.3%
5/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
5.3%
3/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
6/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
22.8%
13/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
3/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
7.0%
4/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
General disorders
Fatigue
|
5.6%
3/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
14.0%
8/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
9.1%
1/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
General disorders
Peripheral swelling
|
0.00%
0/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
9.1%
1/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
General disorders
Asthenia
|
5.6%
3/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
5.3%
3/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
General disorders
Hyperhidrosis
|
1.9%
1/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
8.8%
5/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
3/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
8.8%
5/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
9.1%
1/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
3/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
1.8%
1/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Infections and infestations
Furuncle
|
5.6%
3/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
3/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
3.5%
2/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
General disorders
Pyrexia
|
1.9%
1/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
5.3%
3/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.6%
3/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
1.8%
1/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.6%
3/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
9.1%
1/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Investigations
Lipase increased
|
3.7%
2/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
5.3%
3/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
7.0%
4/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
2/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
5.3%
3/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
3/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
1.8%
1/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Cardiac disorders
Sinus bradycardia
|
7.4%
4/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Vascular disorders
Hypertension
|
1.9%
1/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
5.3%
3/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
9.1%
1/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
9.1%
1/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
9.1%
1/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Investigations
Helicobacter test positive
|
0.00%
0/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
9.1%
1/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
General disorders
Night sweats
|
0.00%
0/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
9.1%
1/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/54 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
0.00%
0/57 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
9.1%
1/11 • Up to 24 weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
|
Additional Information
Clinical Research Director
Crinetics Pharmaceuticals, Inc.
Phone: (833) 276-4636
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60