Trial Outcomes & Findings for Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia (NCT NCT01675154)

NCT ID: NCT01675154

Last Updated: 2021-08-19

Results Overview

Serum triglyceride level will be measured after taking each assigned intervention at first intervention period.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

4 weeks after the assigned treatment (first intervention period)

Results posted on

2021-08-19

Participant Flow

This trial is adaptive design/flexible design. The participants were randomized from the start of the study

Participant milestones

Participant milestones
Measure	SLx-4090 Placebo/Orlistat Placebo First First, SLx-4090 (placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks	Orlistat/SLx-4090 Placebo Then, Orlistat two capsules 60 mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50 mg each, three times per day with meals were administered SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks	Orlistat Placebo /SLx-4090 Then, Orlistat placebo 2 capsules, 60 mg each three times per day with meals. SLx-4090 4 tablets, 50 mg each. three times per day with meals were administered Orlistat Placebo: Given for 4 weeks SLx-4090: Given for 4 weeks	Orlistat/SLx-4090 Then, Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50 mg each, three times per day with meals were administered Orlistat: Given for 4 weeks SLx-4090: Given for 4 weeks
First Intervention Period (4 Weeks) STARTED	2	1	1	1
First Intervention Period (4 Weeks) COMPLETED	2	1	1	1
First Intervention Period (4 Weeks) NOT COMPLETED	0	0	0	0
First Washout Period (1 Week) STARTED	2	1	1	1
First Washout Period (1 Week) COMPLETED	2	1	1	1
First Washout Period (1 Week) NOT COMPLETED	0	0	0	0
Second Intervention Period (4 Weeks) STARTED	1	1	1	2
Second Intervention Period (4 Weeks) COMPLETED	0	1	1	1
Second Intervention Period (4 Weeks) NOT COMPLETED	1	0	0	1
Second Washout Period (1 Week) STARTED	1	1	1	2
Second Washout Period (1 Week) COMPLETED	1	1	1	2
Second Washout Period (1 Week) NOT COMPLETED	0	0	0	0
Third Intervention Period (4 Weeks) STARTED	1	1	1	0
Third Intervention Period (4 Weeks) COMPLETED	1	0	1	0
Third Intervention Period (4 Weeks) NOT COMPLETED	0	1	0	0
Third Washout Period (1 Week) STARTED	1	0	1	0
Third Washout Period (1 Week) COMPLETED	1	0	1	0
Third Washout Period (1 Week) NOT COMPLETED	0	0	0	0
Fourth Intervention Period (4 Weeks) STARTED	1	0	1	0
Fourth Intervention Period (4 Weeks) COMPLETED	1	0	1	0
Fourth Intervention Period (4 Weeks) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	SLx-4090 Placebo/Orlistat Placebo First First, SLx-4090 (placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks	Orlistat/SLx-4090 Placebo Then, Orlistat two capsules 60 mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50 mg each, three times per day with meals were administered SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks	Orlistat Placebo /SLx-4090 Then, Orlistat placebo 2 capsules, 60 mg each three times per day with meals. SLx-4090 4 tablets, 50 mg each. three times per day with meals were administered Orlistat Placebo: Given for 4 weeks SLx-4090: Given for 4 weeks	Orlistat/SLx-4090 Then, Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50 mg each, three times per day with meals were administered Orlistat: Given for 4 weeks SLx-4090: Given for 4 weeks
Third Intervention Period (4 Weeks) Withdrawal by Subject	0	1	0	0

Baseline Characteristics

Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo/Placebo at First Intervention Period n=2 Participants Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals.	Orlistat/Placebo at First Intervention Period n=1 Participants Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals were administered.	Orlistat Placebo /Slx-4090 at First Intervention Period n=1 Participants Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals were administered	Orlistat/SLx-4090 at First Intervention Period n=1 Participants Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals were administered.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
BMI <18.5 kg/m^2	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
BMI 18.5 kg/m^2-24.9 kg/m^2	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants
BMI 25 kg/m^2-29.9 kg/m^2	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
BMI 30 kg/m^2-34.9 kg/m^2	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
BMI 35 kg/m^2-39.9 kg/m^2	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
BMI >=40 kg/m^2	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Triglycerides	1969 mg/dL STANDARD_DEVIATION 419 • n=5 Participants	4840 mg/dL STANDARD_DEVIATION 0 • n=7 Participants	814 mg/dL STANDARD_DEVIATION 0 • n=5 Participants	2061 mg/dL STANDARD_DEVIATION 0 • n=4 Participants	2421 mg/dL STANDARD_DEVIATION 1480 • n=21 Participants

PRIMARY outcome

Timeframe: 4 weeks after the assigned treatment (first intervention period)

Population: This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.

Serum triglyceride level will be measured after taking each assigned intervention at first intervention period.

Outcome measures

Outcome measures
Measure	SLx-4090 Placebo/Orlistat Placebo n=2 Participants Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks	Orlistat/Placebo n=1 Participants Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks	Orlistat Placebo /Slx-4090 n=1 Participants Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals. Orlistat Placebo: Given for 4 weeks Slx-4090: Given for 4 weeks	Orlistat/SLx-4090 n=1 Participants Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks
Serum Triglycerides at First Intervention Period	2086 mg/dL Standard Deviation 481.54	3320 mg/dL	1576 mg/dL	1280 mg/dL

PRIMARY outcome

Timeframe: 4 weeks after the assigned treatment (Second Intervention Period)

Population: Patient assigned to SLX-4090 placebo/Orlistat placebo group withdrew from the study in this phase. One more subject was assigned to the Orlistat/SLx-4090 but could not start the study as the drug SLx-4090 was not available. This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.

Serum triglyceride level will be measured after taking each assigned intervention at second intervention period

Outcome measures

Outcome measures
Measure	SLx-4090 Placebo/Orlistat Placebo Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks	Orlistat/Placebo n=1 Participants Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks	Orlistat Placebo /Slx-4090 n=1 Participants Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals. Orlistat Placebo: Given for 4 weeks Slx-4090: Given for 4 weeks	Orlistat/SLx-4090 n=1 Participants Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks
Serum Triglycerides at Second Intervention Period	—	1419 mg/dL	2040 mg/dL	3478 mg/dL

PRIMARY outcome

Timeframe: 4 weeks after the assigned treatment (Third Intervention Period)

Population: Patient assigned to Orlistat/SLX-4090 placebo group did not start the assigned treatment due to lack of drugs. This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.

Serum triglyceride level will be measured after taking each assigned intervention at intervention period

Outcome measures

Outcome measures
Measure	SLx-4090 Placebo/Orlistat Placebo n=1 Participants Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks	Orlistat/Placebo Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks	Orlistat Placebo /Slx-4090 n=1 Participants Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals. Orlistat Placebo: Given for 4 weeks Slx-4090: Given for 4 weeks	Orlistat/SLx-4090 Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks
Serum Triglycerides at Third Intervention Period	6220 mg/dL	—	1320 mg/dL	—

PRIMARY outcome

Timeframe: 4 weeks after the assigned treatment (Fourth Intervention Period)

Population: Patient assigned to Orlistat/SLX-4090 group did not start the assigned treatment due to lack of drugs. This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.

Serum triglyceride level will be measured after taking each assigned intervention at fourth intervention period

Outcome measures

Outcome measures
Measure	SLx-4090 Placebo/Orlistat Placebo n=1 Participants Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks	Orlistat/Placebo Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks	Orlistat Placebo /Slx-4090 n=1 Participants Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals. Orlistat Placebo: Given for 4 weeks Slx-4090: Given for 4 weeks	Orlistat/SLx-4090 Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks
Serum Triglycerides at Fourth Intervention Period	1156 mg/dL	—	2946 mg/dL	—

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1st Intervention Period:SLx-4090 Placebo/Orlistat Placebo n=2 participants at risk Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks	1st Intervention Period:Orlistat/Placebo n=1 participants at risk Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks	1st Intervention Period:Orlistat Placebo /Slx-4090 n=1 participants at risk Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals. Orlistat Placebo: Given for 4 weeks Slx-4090: Given for 4 weeks	1st Intervention Period:Orlistat/SLx-4090 n=1 participants at risk Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks	2nd Intervention Period:SLx-4090 Placebo/Orlistat Placebo n=1 participants at risk Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks	2nd Intervention Period:Orlistat/Placebo n=1 participants at risk Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks	2nd Intervention Period:Orlistat Placebo /Slx-4090 n=1 participants at risk Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks	2nd Intervention Period:Orlistat/SLx-4090 n=2 participants at risk Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks	3rd Intervention Period:SLx-4090 Placebo/Orlistat Placebo n=1 participants at risk Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks	3rd Intervention Period:Orlistat/Placebo n=1 participants at risk Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks	3rd Intervention Period:Orlistat Placebo /Slx-4090 n=1 participants at risk Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks	3rd Intervention Period:Orlistat/SLx-4090 Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks	4th Intervention Period:SLx-4090 Placebo/Orlistat Placebo n=1 participants at risk Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks	4th Intervention Period:Orlistat/Placebo Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks	4th Intervention Period:Orlistat Placebo /Slx-4090 n=1 participants at risk Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks	4th Intervention Period:Orlistat/SLx-4090 Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks
Endocrine disorders Pancreatitis.	0.00% 0/2 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	50.0% 1/2 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	— 0/0 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	— 0/0 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	— 0/0 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.

Other adverse events

Other adverse events
Measure	1st Intervention Period:SLx-4090 Placebo/Orlistat Placebo n=2 participants at risk Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks	1st Intervention Period:Orlistat/Placebo n=1 participants at risk Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks	1st Intervention Period:Orlistat Placebo /Slx-4090 n=1 participants at risk Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals. Orlistat Placebo: Given for 4 weeks Slx-4090: Given for 4 weeks	1st Intervention Period:Orlistat/SLx-4090 n=1 participants at risk Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks	2nd Intervention Period:SLx-4090 Placebo/Orlistat Placebo n=1 participants at risk Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks	2nd Intervention Period:Orlistat/Placebo n=1 participants at risk Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks	2nd Intervention Period:Orlistat Placebo /Slx-4090 n=1 participants at risk Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks	2nd Intervention Period:Orlistat/SLx-4090 n=2 participants at risk Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks	3rd Intervention Period:SLx-4090 Placebo/Orlistat Placebo n=1 participants at risk Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks	3rd Intervention Period:Orlistat/Placebo n=1 participants at risk Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks	3rd Intervention Period:Orlistat Placebo /Slx-4090 n=1 participants at risk Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks	3rd Intervention Period:Orlistat/SLx-4090 Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks	4th Intervention Period:SLx-4090 Placebo/Orlistat Placebo n=1 participants at risk Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat Placebo: Given for 4 weeks	4th Intervention Period:Orlistat/Placebo Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals. SLx-4090 placebo: Given for 4 weeks Orlistat: Given for 4 weeks	4th Intervention Period:Orlistat Placebo /Slx-4090 n=1 participants at risk Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks	4th Intervention Period:Orlistat/SLx-4090 Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. Orlistat: Given for 4 weeks Slx-4090: Given for 4 weeks
Gastrointestinal disorders Increased urgency of passing stool	0.00% 0/2 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	100.0% 1/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/2 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	— 0/0 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	— 0/0 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	— 0/0 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.
Gastrointestinal disorders Diarrhea	0.00% 0/2 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	100.0% 1/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	100.0% 1/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/2 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	— 0/0 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	— 0/0 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	— 0/0 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	100.0% 1/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/2 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	— 0/0 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	— 0/0 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	0.00% 0/1 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.	— 0/0 • Over a period of 1 year . This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment. Includes all participants who started first, second, third and fourth intervention periods. Events were collected separately for each period.

Additional Information

Dr. Abhimanyu Garg

UT Southwestern Medical Center

Phone: 214-648-8295

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place