18 and older, any sex, with Polybrominated Biphenyl Poisoning. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
WeightPrimary· Enrollment, Month 3, Month 6
Participant weight, in kilograms, was measured in light clothing without shoes on a regularly calibrated digital scale.
Enrollment
Group
Value
95% CI
Placebo
91.3
± 16.4
Orlistat Weight Loss Aid
92.3
± 17.8
Month 3 measured per protocol by study staff
Group
Value
95% CI
Placebo
88.6
± 18.1
Orlistat Weight Loss Aid
87.4
± 15.9
Month 3 self-measured by participant
Group
Value
95% CI
Placebo
90.4
± 14.1
Orlistat Weight Loss Aid
93.2
± 20.2
Month 6
Group
Value
95% CI
Placebo
89.2
± 17.1
Orlistat Weight Loss Aid
88.1
± 17.7
Body Mass Index (BMI)Primary· Enrollment, Month 3, Month 6
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.
Enrollment
Group
Value
95% CI
Placebo
32.3
± 5.4
Orlistat Weight Loss Aid
31.7
± 5.0
Month 3 - BMI calculated with weight measured by study staff
Group
Value
95% CI
Placebo
31.5
± 5.9
Orlistat Weight Loss Aid
29.9
± 4.1
Month 3 - BMI calculated with weight self-measured by participant
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).
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.
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.
Enrollment
Group
Value
95% CI
Placebo
0.035
0.021 – 0.056
Orlistat Weight Loss Aid
0.026
0.014 – 0.041
Month 3
Group
Value
95% CI
Placebo
0.031
0.014 – 0.049
Orlistat Weight Loss Aid
0.024
0.014 – 0.044
Month 6
Group
Value
95% CI
Placebo
0.028
0.020 – 0.042
Orlistat Weight Loss Aid
0.025
0.014 – 0.044
Serum Concentration of PCB 138Secondary· Enrollment, Month 3, Month 6
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
Enrollment
Group
Value
95% CI
Placebo
0.081
0.039 – 0.119
Orlistat Weight Loss Aid
0.064
0.040 – 0.111
Month 3
Group
Value
95% CI
Placebo
0.070
0.030 – 0.109
Orlistat Weight Loss Aid
0.066
0.039 – 0.120
Month 6
Group
Value
95% CI
Placebo
0.078
0.036 – 0.108
Orlistat Weight Loss Aid
0.064
0.042 – 0.129
Serum Concentration of PCB 153Secondary· Enrollment, Month 3, Month 6
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.
Enrollment
Group
Value
95% CI
Placebo
0.122
0.060 – 0.184
Orlistat Weight Loss Aid
0.096
0.062 – 0.166
Month 3
Group
Value
95% CI
Placebo
0.100
0.039 – 0.185
Orlistat Weight Loss Aid
0.105
0.059 – 0.179
Month 6
Group
Value
95% CI
Placebo
0.114
0.061 – 0.191
Orlistat Weight Loss Aid
0.105
0.064 – 0.178
Serum Concentration of PCB 180Secondary· Enrollment, Month 3, Month 6
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
Enrollment
Group
Value
95% CI
Placebo
0.116
0.064 – 0.188
Orlistat Weight Loss Aid
0.108
0.076 – 0.165
Month 3
Group
Value
95% CI
Placebo
0.101
0.050 – 0.214
Orlistat Weight Loss Aid
0.114
0.074 – 0.177
Month 6
Group
Value
95% CI
Placebo
0.112
0.060 – 0.190
Orlistat Weight Loss Aid
0.121
0.071 – 0.187
Serum Concentration of Dichlorodiphenyldichloroethylene (DDE)Secondary· Enrollment, Month 3, Month 6
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.
Enrollment
Group
Value
95% CI
Placebo
0.535
0.343 – 0.844
Orlistat Weight Loss Aid
0.490
0.336 – 0.686
Month 3
Group
Value
95% CI
Placebo
0.539
0.305 – 1.005
Orlistat Weight Loss Aid
0.490
0.360 – 0.735
Month 6
Group
Value
95% CI
Placebo
0.573
0.318 – 0.874
Orlistat Weight Loss Aid
0.498
0.359 – 0.768
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 3/49 (6%)
Deaths: 0/49
Orlistat Weight Loss Aid
Serious: 0/51 (0%)
Deaths: 0/51
Serious adverse events (3 terms)
Reaction
System
Placebo
Orlistat Weight Loss Aid
Heart attack
Cardiac disorders
—
—
Hospitalization due to allergic reaction to an antibiotic
General disorders
—
—
Abdominal pain; masses on ovary, liver, and kidney; endometriosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This study will explore whether the use of orlistat results in weight loss that is accompanied by a reduction in the body burdens of polybrominated biphenyls (PBB) and other Persistent Organic Pollutants (POPs).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT06854614 — Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic
· Phase 4
· active not recruiting
NCT05816343 — Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia
· Phase 2
· recruiting
NCT06501326 — Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism Associated Fatty Liver Disease
· Phase 4
· unknown
NCT05579249 — A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America
· Phase 4
· completed
NCT05496075 — Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia
· Phase 4
· completed
Other Emory University trials
Trials by the same sponsor.
NCT06143345 — HIIT in Isolated IFG: A Proof-of-Concept Study
· NA
· withdrawn
NCT07189819 — Innovative Closed-loop Functional Electrical Stimulation Control System for Augmenting Post-stroke Gait
· NA
· not yet recruiting
NCT06451055 — Low-calorie Diet in Isolated Impaired Fasting Glucose
· NA
· not yet recruiting
NCT07405476 — Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative I
· Phase 2
· recruiting
NCT06708351 — Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya, the ENHANCE LINKAge Trial
· NA
· not yet recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 25 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03582722.