Polybrominated Biphenyl PoisoningPhase 4NCT03582722

Weight Loss Aid in an Exposed Population

A Phase 4 study testing Orlistat and Multivitamin in people with Polybrominated Biphenyl Poisoning, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Polybrominated Biphenyl Poisoning
What is being tested?: Orlistat and Multivitamin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 14 Sep 2018to 30 Jun 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

current or recent (within the last five years) serum PBB level of ≥1ppb, or are a member of a sub-group likely to have high serum PBB (former chemical worker, family member of former chemical worker, lived on a farm with animals that were quarantined because of PBB exposure)
at least 18 years old
currently reside in Michigan
able to participate in examinations and laboratory tests (a lipid panel, liver function test, thyroid function and and creatinine levels) done at at a local health department or other medical health facility and to be able to engage in moderate physical activity (e.g. walking)
participants with undiagnosed abdominal pain or diarrhea, Crohn's disease, Ulcerative Colitis, Celiac Disease, treated diabetes or treated thyroid disorder, will only be eligible following consultation with their primary care provider
any participant using levothyroxine will be instructed to take their dosage 4 hours before or after Orlistat in order to maintain eligibility

Who cannot join

BMI<25
abnormal liver function
abnormal creatinine levels
abnormal thyroid levels (TSH)
have type 1 diabetes
have had an organ transplant

Show all 12Show fewer

are pregnant or lactating
current use of weight-loss medications, oral steroids, Coumadin, warfarin or Cyclosporine
have a diagnosed problem absorbing food, or have an eating disorder
a history of bariatric surgery, pancreatitis, kidney stones, gall bladder disorder or a serious chronic disease (e.g. uncontrolled diabetes, congestive heart failure, chronic kidney disease)
allergies to any ingredients of the Orlistat over-the-counter (OTC) capsules
participants will become ineligible at any point during the study if they begin a medical regimen involving any of the above medications

Trial locations and contacts

1 site in 1 country.

United States1 site

Michele Marcus
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Use of a Weight Loss Aid in a Population Exposed to Polybrominated Biphenyls (PBB)

Read the detailed description

Millions of people living in Michigan were exposed to brominated flame retardants (polybrominated biphenyls or PBB) as a result of the largest agricultural disaster in US history. Over the past six years, Emory researchers have tested nearly 900 Michigan residents and determined that 60% still had PBB in their bodies from that disaster. PBB is stored in body fat and the researchers at Emory have been asked by community members if weight loss might reduce their body burdens of PBB and other lipophilic chemicals. In an effort to understand how PBB and other persistent organic pollutants (POPs) are eliminated, the researchers are conducting a randomized trial of orlistat versus placebo.

Orlistat is an over-the-counter product approved by the FDA for weight loss and works by increasing excretion of fat into the stool. Since PBB is stored in body fat, the researchers hypothesize that orlistat may reduce the body burden of PBB and other POPs. This study is a randomized, placebo-controlled trial of orlistat (at the dose available over-the-counter) plus diet and exercise for 6 months in a population with elevated PBB levels. Participants will be healthy overweight adults and orlistat will be taken as directed for the approved indication (weight loss).

Conditions: Polybrominated Biphenyl Poisoning
Being tested: Orlistat, Placebo capsule, Multivitamin
Keywords: Polybrominated Biphenyl Exposure, Gastrointestinal lipase inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OrlistatDrug
Also called Alli
Participants will be instructed to take one 60mg capsule of orlistat with each meal containing fat, up to three capsules daily, for six months.
Placebo capsuleDrug
Participants will be instructed to take one placebo capsule to match 60mg of orlistat with each meal containing fat, up to three capsules daily, for six months.
MultivitaminDietary supplement
A multivitamin will be provided to be taken once daily, at bedtime.

Study groups in NCT03582722
Study group	Role	What they receive
Orlistat Weight Loss Aid	Experimental	Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin will also be recommended and monitored. Receives: Drug: Orlistat; Dietary Supplement: Multivitamin
Placebo	Placebo comparator	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 will also be recommended and monitored. Receives: Drug: Placebo capsule; Dietary Supplement: Multivitamin

What is being measured

The primary outcome is the main question the study is designed to answer.

Weight
Participant weight, in kilograms, was measured in light clothing without shoes on a regularly calibrated digital scale.
Measured: Enrollment, Month 3, Month 6
Body Mass Index (BMI)
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.
Measured: Enrollment, Month 3, Month 6

Secondary outcomes (7)

Serum Concentration of Polybrominated Biphenyl (PBB) 153
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).
Measured: Enrollment, Month 3, Month 6
Serum Concentration of Polybrominated Diphenyl Ether (PBDE) 47
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.
Measured: Enrollment, Month 3, Month 6
Serum Concentration of Polychlorinated Biphenyl (PCB) 118
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.
Measured: Enrollment, Month 3, Month 6
Serum Concentration of PCB 138
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
Measured: Enrollment, Month 3, Month 6
Serum Concentration of PCB 153
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.
Measured: Enrollment, Month 3, Month 6
Serum Concentration of PCB 180
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
Measured: Enrollment, Month 3, Month 6
Serum Concentration of Dichlorodiphenyldichloroethylene (DDE)
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.
Measured: Enrollment, Month 3, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 201830 Jun 2022

First posted11 Jul 2018
Study start14 Sep 2018
Primary completion30 Jun 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Polybrominated Biphenyl PoisoningStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03582722
Sponsor's protocol ID: IRB00099231
Other IDs: R01ES025775
Status last verified: Sep 2026
First submitted: 28 Jun 2018
Last updated: 20 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Terrell ML, Tomlinson MS, Wolfe J, Hood RB, Pearson MA, Barton H, Dadani S, Morse J, Barr DB, Havlicek B, Fremion BB, Jelenek J, Keon N, Corbett TH, Montoye AHK, Hartman TJ, Manatunga A, Marcus M. A community-engaged randomized controlled trial assessing the effectiveness of a weight loss aid in reducing the body burden of persistent organic pollutants. Environ Adv. 2026 Oct;25:100742. doi: 10.1016/j.envadv.2026.100742. Epub 2026 Jul 31.
PubMed 42746240

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of a Weight Loss Aid in a Population Exposed to Polybrominated Biphenyls (PBB)
ClinicalTrials.gov ID: NCT03582722
Acronym / sponsor ID: IRB00099231
Conditions: Polybrominated Biphenyl Poisoning
Keywords: Polybrominated Biphenyl Exposure, Gastrointestinal lipase inhibitor
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: Healthway Compounding Pharmacy, Michigan Public Health Departments, National Institute of Environmental Health Sciences (NIEHS)
Study start: 14 Sep 2018 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 11 Jul 2018 (actual)
Results: Posted 25 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Orlistat Weight Loss Aid	Experimental	Drug: Orlistat, Dietary Supplement: MultivitaminParticipants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin will also be recommended and monitored.
Placebo	Placebo comparator	Drug: Placebo capsule, Dietary Supplement: MultivitaminParticipants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin will also be recommended and monitored.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

current or recent (within the last five years) serum PBB level of ≥1ppb, or are a member of a sub-group likely to have high serum PBB (former chemical worker, family member of former chemical worker, lived on a farm with animals that were quarantined because of PBB exposure)
at least 18 years old
currently reside in Michigan
able to participate in examinations and laboratory tests (a lipid panel, liver function test, thyroid function and and creatinine levels) done at at a local health department or other medical health facility and to be able to engage in moderate physical activity (e.g. walking)
participants with undiagnosed abdominal pain or diarrhea, Crohn's disease, Ulcerative Colitis, Celiac Disease, treated diabetes or treated thyroid disorder, will only be eligible following consultation with their primary care provider

Key exclusion criteria (12 listed)

BMI<25
abnormal liver function
abnormal creatinine levels
abnormal thyroid levels (TSH)
have type 1 diabetes

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OrlistatAlso: AlliParticipants will be instructed to take one 60mg capsule of orlistat with each meal containing fat, up to three capsules daily, for six months.	Drug	Orlistat Weight Loss Aid
Placebo capsuleParticipants will be instructed to take one placebo capsule to match 60mg of orlistat with each meal containing fat, up to three capsules daily, for six months.	Drug	Placebo
MultivitaminA multivitamin will be provided to be taken once daily, at bedtime.	Dietary supplement	Orlistat Weight Loss Aid, Placebo

Primary outcome

Weight
Time frame: Enrollment, Month 3, Month 6
Participant weight, in kilograms, was measured in light clothing without shoes on a regularly calibrated digital scale.
Body Mass Index (BMI)
Time frame: 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.

7 secondary outcomes

Serum Concentration of Polybrominated Biphenyl (PBB) 153
Time frame: Enrollment, Month 3, Month 6
Serum Concentration of Polybrominated Diphenyl Ether (PBDE) 47
Time frame: Enrollment, Month 3, Month 6
Serum Concentration of Polychlorinated Biphenyl (PCB) 118
Time frame: Enrollment, Month 3, Month 6
Serum Concentration of PCB 138
Time frame: Enrollment, Month 3, Month 6
Serum Concentration of PCB 153
Time frame: Enrollment, Month 3, Month 6
Serum Concentration of PCB 180
Time frame: Enrollment, Month 3, Month 6
Serum Concentration of Dichlorodiphenyldichloroethylene (DDE)
Time frame: Enrollment, Month 3, Month 6

Results and safety

Results posted to the registry on 25 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	49	45
Orlistat Weight Loss Aid	51	44

Primary outcome: Weight

Time frame: Enrollment, Month 3, Month 6. Mean (Standard Deviation). Unit: kilograms (kg)

Measure	Placebo n = 46	Orlistat Weight Loss Aid n = 45
Enrollment	91.3 (16.4)	92.3 (17.8)
Month 3 measured per protocol by study staff	88.6 (18.1)	87.4 (15.9)
Month 3 self-measured by participant	90.4 (14.1)	93.2 (20.2)
Month 6	89.2 (17.1)	88.1 (17.7)

Population analysed: 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.

Primary outcome: Body Mass Index (BMI)

Time frame: Enrollment, Month 3, Month 6. Mean (Standard Deviation). Unit: kg/m^2

Measure	Placebo n = 46	Orlistat Weight Loss Aid n = 45
Enrollment	32.3 (5.4)	31.7 (5.0)
Month 3 - BMI calculated with weight measured by study staff	31.5 (5.9)	29.9 (4.1)
Month 3 - BMI calculated with weight self-measured by participant	31.6 (5.6)	32.3 (6.4)
Month 6	31.4 (5.8)	30.2 (5.0)

Population analysed: 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.

7 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 49 (6.1%)	28 of 49 (57.1%)	0 of 49
Orlistat Weight Loss Aid	0 of 51 (0%)	41 of 51 (80.4%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 42746240Terrell ML, Tomlinson MS, Wolfe J, Hood RB, Pearson MA, Barton H, Dadani S, Morse J, Barr DB, Havlicek B, Fremion BB, Jelenek J, Keon N, Corbett TH, Montoye AHK, Hartman TJ, Manatunga A, Marcus M. A community-engaged randomized controlled trial assessing the effectiveness of a weight loss aid in reducing the body burden of persistent organic pollutants. Environ Adv. 2026 Oct;25:100742. doi: 10.1016/j.envadv.2026.100742. Epub 2026 Jul 31.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michele Marcus, PhD, MPH principal investigator

School of Public Health, Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Orlistat and Multivitamin in people with Polybrominated Biphenyl Poisoning, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: Enrollment, Month 3, Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03582722, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 2 Nov 2026.