Trial Outcomes & Findings for Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity (NCT NCT01351753)

Results Overview

Weight obtained in the fasting state on a gowned subject.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

128 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2026-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	Metformin Metformin only	Metformin + Orlistat Metformin Orlistat	Metformin + Topiramate Metformin Topiramate	Topiramate Topiramate only	Metformin + Topiramate + Orlistat Metformin Orlistat Topiramate	Placebo Placebo: Placebo pills and capsules for metformin, orlistat and topiramate
Overall Study STARTED	22	20	21	21	21	23
Overall Study COMPLETED	15	13	14	21	14	22
Overall Study NOT COMPLETED	7	7	7	0	7	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metformin n=22 Participants Metformin only	Metformin + Orlistat n=20 Participants Metformin Orlistat	Metformin + Topiramate n=21 Participants Metformin Topiramate	Topiramate n=21 Participants Topiramate only	Metformin + Topiramate + Orlistat n=21 Participants Metformin Orlistat Topiramate	Placebo n=23 Participants Placebo: Placebo pills and capsules for metformin, orlistat and topiramate	Total n=128 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants	0 Participants n=60 Participants	0 Participants n=3 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=9 Participants	20 Participants n=9 Participants	21 Participants n=18 Participants	21 Participants n=15 Participants	19 Participants n=60 Participants	23 Participants n=3 Participants	125 Participants n=21 Participants
Age, Categorical >=65 years	1 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants	2 Participants n=60 Participants	0 Participants n=3 Participants	3 Participants n=21 Participants
Age, Continuous	55.04 years STANDARD_DEVIATION 7.14 • n=9 Participants	55.09 years STANDARD_DEVIATION 7.46 • n=9 Participants	54.19 years STANDARD_DEVIATION 6.06 • n=18 Participants	54.3 years STANDARD_DEVIATION 9.05 • n=15 Participants	56.14 years STANDARD_DEVIATION 9.05 • n=60 Participants	55.78 years STANDARD_DEVIATION 7.89 • n=3 Participants	55.13 years STANDARD_DEVIATION 7.75 • n=21 Participants
Sex: Female, Male Female	14 Participants n=9 Participants	13 Participants n=9 Participants	14 Participants n=18 Participants	13 Participants n=15 Participants	13 Participants n=60 Participants	16 Participants n=3 Participants	83 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=9 Participants	7 Participants n=9 Participants	7 Participants n=18 Participants	8 Participants n=15 Participants	8 Participants n=60 Participants	7 Participants n=3 Participants	45 Participants n=21 Participants
Region of Enrollment United States	22 participants n=9 Participants	20 participants n=9 Participants	21 participants n=18 Participants	21 participants n=15 Participants	21 participants n=60 Participants	23 participants n=3 Participants	128 participants n=21 Participants
Weight	22 Participants n=9 Participants	20 Participants n=9 Participants	21 Participants n=18 Participants	21 Participants n=15 Participants	21 Participants n=60 Participants	23 Participants n=3 Participants	128 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Weight obtained in the fasting state on a gowned subject.

Outcome measures

Outcome measures
Measure	Metformin n=22 Participants Metformin	Metformin + Orlistat n=20 Participants Metformin Orlistat	Metformin + Topiramate n=21 Participants Metformin Topiramate	Topiramate n=21 Participants Topiramate	Metformin + Topiramate + Orlistat n=21 Participants Metformin Orlistat Topiramate	Placebo n=23 Participants Placebo: Placebo pills and capsules for metformin, orlistat and topiramate
Weight (Percent Change From Baseline)	-10.9 percentage of weight change Interval -14.4 to -7.2	-10.5 percentage of weight change Interval -14.0 to -6.9	-14.0 percentage of weight change Interval -17.3 to -10.5	-12.2 percentage of weight change Interval -15.6 to -8.6	-16.7 percentage of weight change Interval -20.3 to -13.0	-6.7 percentage of weight change Interval -10.5 to -2.7

SECONDARY outcome

Timeframe: Baseline and 6 months

Automated sphygmomanometry while sitting

Outcome measures

Outcome measures
Measure	Metformin n=15 Participants Metformin	Metformin + Orlistat n=13 Participants Metformin Orlistat	Metformin + Topiramate n=14 Participants Metformin Topiramate	Topiramate n=21 Participants Topiramate	Metformin + Topiramate + Orlistat n=14 Participants Metformin Orlistat Topiramate	Placebo n=22 Participants Placebo: Placebo pills and capsules for metformin, orlistat and topiramate
Office Systolic Blood Pressure (mmHg Change From Baseline)	-11.42 mmHg Interval -21.1 to -1.74	-11.41 mmHg Interval -20.88 to -1.94	-10.33 mmHg Interval -19.52 to -1.14	-8.55 mmHg Interval -18.53 to 1.44	-14.47 mmHg Interval -24.87 to -4.08	-13.26 mmHg Interval -23.28 to -3.23

SECONDARY outcome

Timeframe: Baseline and 6 months

Waist circumference for central adiposity

Outcome measures

Outcome measures
Measure	Metformin n=15 Participants Metformin	Metformin + Orlistat n=13 Participants Metformin Orlistat	Metformin + Topiramate n=14 Participants Metformin Topiramate	Topiramate n=21 Participants Topiramate	Metformin + Topiramate + Orlistat n=14 Participants Metformin Orlistat Topiramate	Placebo n=22 Participants Placebo: Placebo pills and capsules for metformin, orlistat and topiramate
Centimeter Change in Waist Circumference	-10.62 cm change Interval -20.48 to -0.77	-9.04 cm change Interval -18.78 to -0.78	-11.65 cm change Interval -21.2 to -2.11	-16.63 cm change Interval -26.59 to -6.66	-15.76 cm change Interval -26.44 to -5.08	-10.78 cm change Interval -20.79 to -0.78

SECONDARY outcome

Timeframe: Baseline and 6 months

Change in carotid-femoral pulse wave velocity in meters/second (Sphygmocor).