Trial Outcomes & Findings for Weight Loss Aid in an Exposed Population (NCT NCT03582722)

NCT ID: NCT03582722

Last Updated: 2024-04-25

Results Overview

Participant weight, in kilograms, was measured in light clothing without shoes on a regularly calibrated digital scale.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: Enrollment, Month 3, Month 6
• Results posted on: 2024-04-25

Participant Flow

Participants were recruited from the Michigan polybrominated biphenyls (PBB) Research Registry. Participant enrollment began September 14, 2018 and all follow-up assessments were completed by June 30, 2022.

100 individuals gave consent to participate in the study and were randomized to a study arm. One participant who was randomized to the Orlistat arm did not begin taking the study medication and did not complete the first study visit.

Participant milestones

Measure	Placebo Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored. Placebo capsule: Participants were instructed to take one placebo capsule to match 60mg of orlistat with each meal containing fat, up to three capsules daily, for six months. Multivitamin: A multivitamin was provided to be taken once daily, at bedtime.	Orlistat Weight Loss Aid Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored. Orlistat: Participants were instructed to take one 60mg capsule of orlistat with each meal containing fat, up to three capsules daily, for six months. Multivitamin: A multivitamin was provided to be taken once daily, at bedtime.
Overall Study STARTED	49	51
Overall Study Completed the Enrollment Visit and Initiated Study Medication	49	50
Overall Study Completed the 3 Month Follow-up Visit	46	45
Overall Study COMPLETED	45	44
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Measure	Placebo Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored. Placebo capsule: Participants were instructed to take one placebo capsule to match 60mg of orlistat with each meal containing fat, up to three capsules daily, for six months. Multivitamin: A multivitamin was provided to be taken once daily, at bedtime.	Orlistat Weight Loss Aid Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored. Orlistat: Participants were instructed to take one 60mg capsule of orlistat with each meal containing fat, up to three capsules daily, for six months. Multivitamin: A multivitamin was provided to be taken once daily, at bedtime.
Overall Study Lost to Follow-up	1	4
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

Weight Loss Aid in an Exposed Population

Baseline characteristics by cohort

Measure	Placebo n=46 Participants Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.	Orlistat Weight Loss Aid n=45 Participants Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.	Total n=91 Participants Total of all reporting groups
Age, Continuous	59.4 years STANDARD_DEVIATION 9.9 • n=5 Participants	59.5 years STANDARD_DEVIATION 9.3 • n=7 Participants	59.4 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	43 Participants n=7 Participants	89 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	43 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	46 Participants n=5 Participants	45 Participants n=7 Participants	91 Participants n=5 Participants

PRIMARY outcome

Timeframe: Enrollment, Month 3, Month 6

Population: This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-five participants were not able to attend the Month 3 study visit in person; 23 due to the Coronavirus 2019 (COVID-19) pandemic and an additional 2 due to other reasons. All of participants who were unable to have the in-person Month 3 visit provided a self-measured weight. Mean weights measured per protocol and self-measured are reported separately.

Participant weight, in kilograms, was measured in light clothing without shoes on a regularly calibrated digital scale.

Outcome measures

Measure	Placebo n=46 Participants Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.	Orlistat Weight Loss Aid n=45 Participants Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.
Weight Enrollment	91.3 kilograms (kg) Standard Deviation 16.4	92.3 kilograms (kg) Standard Deviation 17.8
Weight Month 3 measured per protocol by study staff	88.6 kilograms (kg) Standard Deviation 18.1	87.4 kilograms (kg) Standard Deviation 15.9
Weight Month 3 self-measured by participant	90.4 kilograms (kg) Standard Deviation 14.1	93.2 kilograms (kg) Standard Deviation 20.2
Weight Month 6	89.2 kilograms (kg) Standard Deviation 17.1	88.1 kilograms (kg) Standard Deviation 17.7

PRIMARY outcome

Timeframe: Enrollment, Month 3, Month 6

Population: This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-five participants were not able to attend the Month 3 study visit in person; 23 due to the COVID-19 pandemic and an additional 2 due to other reasons. All of participants who were unable to have the in-person Month 3 visit provided a self-measured weight. Mean BMI calculated using weight measured per protocol and self-measured are reported separately.

Body Mass Index is a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters and used as an indicator of obesity and underweight. Participants had their weight measured in light clothing without shoes on a regularly calibrated digital scale. Height is measured using a well-mounted stadiometer.

Outcome measures

Measure	Placebo n=46 Participants Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.	Orlistat Weight Loss Aid n=45 Participants Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.
Body Mass Index (BMI) Enrollment	32.3 kg/m^2 Standard Deviation 5.4	31.7 kg/m^2 Standard Deviation 5.0
Body Mass Index (BMI) Month 3 - BMI calculated with weight measured by study staff	31.5 kg/m^2 Standard Deviation 5.9	29.9 kg/m^2 Standard Deviation 4.1
Body Mass Index (BMI) Month 3 - BMI calculated with weight self-measured by participant	31.6 kg/m^2 Standard Deviation 5.6	32.3 kg/m^2 Standard Deviation 6.4
Body Mass Index (BMI) Month 6	31.4 kg/m^2 Standard Deviation 5.8	30.2 kg/m^2 Standard Deviation 5.0

SECONDARY outcome

Timeframe: Enrollment, Month 3, Month 6

Population: This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-three participants were not able to attend the Month 3 study visit in person due to the COVID-19 pandemic and did not have blood drawn at this time point. An additional 2 participants did not attend the Month 3 visit in person and one had blood collected and shipped to the study lab by their physician.

PBB is an organic bromine compound that is environmentally toxic and is classified as a persistent organic pollutant. PBB 153 concentration in serum is measured in nanograms per milliliter (ng/mL).

Outcome measures

Measure	Placebo n=46 Participants Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.	Orlistat Weight Loss Aid n=45 Participants Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.
Serum Concentration of Polybrominated Biphenyl (PBB) 153 Enrollment	0.454 ng/mL Interval 0.156 to 1.711	0.276 ng/mL Interval 0.145 to 0.751
Serum Concentration of Polybrominated Biphenyl (PBB) 153 Month 3	0.355 ng/mL Interval 0.084 to 1.846	0.395 ng/mL Interval 0.201 to 0.801
Serum Concentration of Polybrominated Biphenyl (PBB) 153 Month 6	0.481 ng/mL Interval 0.121 to 1.51	0.290 ng/mL Interval 0.131 to 0.889

SECONDARY outcome

Timeframe: Enrollment, Month 3, Month 6

Population: This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-three participants were not able to attend the Month 3 study visit in person due to the COVID-19 pandemic and did not have blood drawn at this time point. An additional 2 participants did not attend the Month 3 visit in person and one had blood collected and shipped to the study lab by their physician.

PBDE is an organic bromine compound that is environmentally toxic and is classified as a persistent organic pollutant. PBDE 47 concentration in serum is measured in ng/mL.

Outcome measures

Measure	Placebo n=46 Participants Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.	Orlistat Weight Loss Aid n=45 Participants Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.
Serum Concentration of Polybrominated Diphenyl Ether (PBDE) 47 Enrollment	0.032 ng/mL Interval 0.015 to 0.059	0.028 ng/mL Interval 0.016 to 0.053
Serum Concentration of Polybrominated Diphenyl Ether (PBDE) 47 Month 3	0.034 ng/mL Interval 0.015 to 0.057	0.025 ng/mL Interval 0.009 to 0.047
Serum Concentration of Polybrominated Diphenyl Ether (PBDE) 47 Month 6	0.029 ng/mL Interval 0.017 to 0.056	0.025 ng/mL Interval 0.012 to 0.047

SECONDARY outcome

Timeframe: Enrollment, Month 3, Month 6

Population: This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-three participants were not able to attend the Month 3 study visit in person due to the COVID-19 pandemic and did not have blood drawn at this time point. An additional 2 participants did not attend the Month 3 visit in person and one had blood collected and shipped to the study lab by their physician.

PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. PCB 118 concentration in serum is measured in ng/mL.

Outcome measures

Measure	Placebo n=46 Participants Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.	Orlistat Weight Loss Aid n=45 Participants Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.
Serum Concentration of Polychlorinated Biphenyl (PCB) 118 Month 3	0.031 ng/mL Interval 0.014 to 0.049	0.024 ng/mL Interval 0.014 to 0.044
Serum Concentration of Polychlorinated Biphenyl (PCB) 118 Enrollment	0.035 ng/mL Interval 0.021 to 0.056	0.026 ng/mL Interval 0.014 to 0.041
Serum Concentration of Polychlorinated Biphenyl (PCB) 118 Month 6	0.028 ng/mL Interval 0.02 to 0.042	0.025 ng/mL Interval 0.014 to 0.044

SECONDARY outcome

Timeframe: Enrollment, Month 3, Month 6

Population: This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-three participants were not able to attend the Month 3 study visit in person due to the COVID-19 pandemic and did not have blood drawn at this time point. An additional 2 participants did not attend the Month 3 visit in person and one had blood collected and shipped to the study lab by their physician.

PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. PCB 138 concentration in serum is measured in ng/mL

Outcome measures

Measure	Placebo n=46 Participants Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.	Orlistat Weight Loss Aid n=45 Participants Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.
Serum Concentration of PCB 138 Enrollment	0.081 ng/mL Interval 0.039 to 0.119	0.064 ng/mL Interval 0.04 to 0.111
Serum Concentration of PCB 138 Month 3	0.070 ng/mL Interval 0.03 to 0.109	0.066 ng/mL Interval 0.039 to 0.12
Serum Concentration of PCB 138 Month 6	0.078 ng/mL Interval 0.036 to 0.108	0.064 ng/mL Interval 0.042 to 0.129

SECONDARY outcome

Timeframe: Enrollment, Month 3, Month 6

Population: This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-three participants were not able to attend the Month 3 study visit in person due to the COVID-19 pandemic and did not have blood drawn at this time point. An additional 2 participants did not attend the Month 3 visit in person and one had blood collected and shipped to the study lab by their physician.

PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. PCB 153 concentration in serum is measured in ng/mL.

Outcome measures

Measure	Placebo n=46 Participants Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.	Orlistat Weight Loss Aid n=45 Participants Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.
Serum Concentration of PCB 153 Enrollment	0.122 ng/mL Interval 0.06 to 0.184	0.096 ng/mL Interval 0.062 to 0.166
Serum Concentration of PCB 153 Month 3	0.100 ng/mL Interval 0.039 to 0.185	0.105 ng/mL Interval 0.059 to 0.179
Serum Concentration of PCB 153 Month 6	0.114 ng/mL Interval 0.061 to 0.191	0.105 ng/mL Interval 0.064 to 0.178

SECONDARY outcome

Timeframe: Enrollment, Month 3, Month 6

Population: This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-three participants were not able to attend the Month 3 study visit in person due to the COVID-19 pandemic and did not have blood drawn at this time point. An additional 2 participants did not attend the Month 3 visit in person and one had blood collected and shipped to the study lab by their physician.

PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. PCB 180 concentration in serum is measured in ng/mL

Outcome measures

Measure	Placebo n=46 Participants Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.	Orlistat Weight Loss Aid n=45 Participants Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.
Serum Concentration of PCB 180 Enrollment	0.116 ng/mL Interval 0.064 to 0.188	0.108 ng/mL Interval 0.076 to 0.165
Serum Concentration of PCB 180 Month 3	0.101 ng/mL Interval 0.05 to 0.214	0.114 ng/mL Interval 0.074 to 0.177
Serum Concentration of PCB 180 Month 6	0.112 ng/mL Interval 0.06 to 0.19	0.121 ng/mL Interval 0.071 to 0.187

SECONDARY outcome

Timeframe: Enrollment, Month 3, Month 6

Population: This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-three participants were not able to attend the Month 3 study visit in person due to the COVID-19 pandemic and did not have blood drawn at this time point. An additional 2 participants did not attend the Month 3 visit in person and one had blood collected and shipped to the study lab by their physician.

DDE is a chemical produced by the breakdown of dichlorodiphenyltrichloroethane (DDT). High levels of DDE can impact lactation and increase the risk of preterm birth. DDE concentration in serum is measured in ng/mL.

Outcome measures

Measure	Placebo n=46 Participants Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.	Orlistat Weight Loss Aid n=45 Participants Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.
Serum Concentration of Dichlorodiphenyldichloroethylene (DDE) Enrollment	0.535 ng/mL Interval 0.343 to 0.844	0.490 ng/mL Interval 0.336 to 0.686
Serum Concentration of Dichlorodiphenyldichloroethylene (DDE) Month 3	0.539 ng/mL Interval 0.305 to 1.005	0.490 ng/mL Interval 0.36 to 0.735
Serum Concentration of Dichlorodiphenyldichloroethylene (DDE) Month 6	0.573 ng/mL Interval 0.318 to 0.874	0.498 ng/mL Interval 0.359 to 0.768

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

Orlistat Weight Loss Aid

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=49 participants at risk Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.	Orlistat Weight Loss Aid n=51 participants at risk Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.
Cardiac disorders Heart attack	2.0% 1/49 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.	0.00% 0/51 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.
General disorders Hospitalization due to allergic reaction to an antibiotic	2.0% 1/49 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.	0.00% 0/51 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal pain; masses on ovary, liver, and kidney; endometriosis	2.0% 1/49 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.	0.00% 0/51 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.

Other adverse events

Measure	Placebo n=49 participants at risk Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.	Orlistat Weight Loss Aid n=51 participants at risk Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.
General disorders Headache	10.2% 5/49 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.	11.8% 6/51 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.
General disorders Dizziness	0.00% 0/49 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.	5.9% 3/51 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.
Gastrointestinal disorders Diarrhea and frequent or oily bowel movements	26.5% 13/49 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.	54.9% 28/51 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.
Gastrointestinal disorders Stomach ache or gassy	10.2% 5/49 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.	2.0% 1/51 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.
Infections and infestations Cold/flu/respiratory symptoms	24.5% 12/49 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.	27.5% 14/51 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.
Infections and infestations COVID-19	6.1% 3/49 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.	3.9% 2/51 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.
General disorders Falls	2.0% 1/49 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.	5.9% 3/51 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.
General disorders Fatigue	0.00% 0/49 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.	5.9% 3/51 • Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.

Additional Information

Michele Marcus, PhD, MPH

Emory University

Phone: 404-727-8010

Email: mmarcus@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place