Your session is about to expire
← Back to Search
Sympathomimetic Appetite Suppressant
Phentermine for Obesity (LEAP Trial)
Phase 4
Recruiting
Led By Nicholas M Pajewski, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI 30-44.9 kg/m2 or BMI 27-29.9 with weight related comorbidity (including hypertension, prediabetes, type 2 diabetes mellitus, dyslipidemia, nonalcoholic fatty liver disease, treated obstructive sleep apnea, osteoarthritis, low back pain, gastroesophageal reflux disease)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1, month 2, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
Awards & highlights
LEAP Trial Summary
This trial is designed to study the long-term effects of the drug phentermine on weight, blood pressure, and other health outcomes.
Who is the study for?
This trial is for English-speaking adults with obesity (BMI 30-44.9 or BMI 27-29.9 with certain health issues) who are willing to follow a treatment plan and have internet access for online therapy. Women must use effective contraception. Exclusions include recent drug abuse, severe kidney/liver disease, past weight control procedures, recent use of similar medications or significant weight changes, certain heart conditions, heavy alcohol use, pregnancy/breastfeeding intentions within two years, mental health hospitalizations in the last two years.Check my eligibility
What is being tested?
The study examines the long-term effects (up to 2 years) of phentermine on weight management and safety compared to an online lifestyle behavioral therapy program without medication. Phentermine has been FDA-approved for short-term use since 1959; this trial seeks data on its extended usage.See study design
What are the potential side effects?
Potential side effects of phentermine may include increased blood pressure and heart rate, dry mouth, sleeplessness, nervousness and constipation. Long-term side effect profiles will be closely monitored given that phentermine is typically approved only for short-term use.
LEAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 30-44.9, or 27-29.9 with a weight-related health issue.
LEAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 1, month 2, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1, month 2, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in Systolic Blood Pressure (mmHg)
Change in cardiac autonomic function
Change in resting energy expenditure (REE) / resting metabolic rate (RMR)
+1 moreOther outcome measures
Change in body weight (%)
Change in self-reported physical activity levels
Incident cardiovascular disease or death
LEAP Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PhentermineExperimental Treatment2 Interventions
Participants randomized to active treatment in LEAP will be provided with phentermine hydrochloride 8 mg scored tablets. This formulation of the drug is commercially available and marketed as Lomaira TM.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to the control arm of LEAP will be provided with placebo tablets consisting of cellulose and corn starch and manufactured to have the same characteristics of the active drug, including size, shape, weight, and sensory perceptions.
Find a Location
Who is running the clinical trial?
Weight Watchers InternationalIndustry Sponsor
22 Previous Clinical Trials
4,201 Total Patients Enrolled
12 Trials studying Obesity
2,450 Patients Enrolled for Obesity
The University of Texas Health Science Center, HoustonOTHER
904 Previous Clinical Trials
319,960 Total Patients Enrolled
27 Trials studying Obesity
14,406 Patients Enrolled for Obesity
Biomedical Research Institute of New MexicoOTHER
9 Previous Clinical Trials
1,297 Total Patients Enrolled
2 Trials studying Obesity
280 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have glaucoma or am at high risk for it.I have been diagnosed with dementia or a serious mental illness.I haven't changed my weight-loss medication dose in the last year.I have not used any monoamine oxidase inhibitors in the last 14 days.I haven't taken phentermine or similar weight-loss drugs in the last 2 years.I stopped using nicotine products less than 6 months ago or plan to quit within 2 years.I am experiencing high levels of depression.I have not used illegal drugs in the past year, excluding THC products.I have a history of heart or blood vessel diseases.I have anxiety symptoms that are not well-managed.I have severe kidney disease or am on dialysis.I have undergone a procedure to help control my weight.I have had an organ transplant.I am willing and able to follow all study rules and attend all appointments.My blood pressure is high or my heart beats very fast.I have not had heavy alcohol use in the last 6 months.I have not had any cancer except for non-melanoma skin cancer in the last 5 years.I haven't taken any weight loss drugs other than phentermine in the last year.I am willing to lose weight through treatment.My weight has changed by more than 5% in the last 3 months.I have used oral corticosteroids for more than 5 days a month in the last 3 months.I can take pills and follow the study's visit and treatment plan.I need extra oxygen due to severe lung problems.I have a history of heart valve disease.I have a history of irregular heartbeats.I am currently being treated for an overactive thyroid.My BMI is between 30-44.9, or 27-29.9 with a weight-related health issue.I have a history of or currently have congestive heart failure.I have not had cirrhosis or symptoms of liver failure in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Phentermine
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT05176626 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently engaging in this research endeavor?
"Affirmative. Clinicaltrials.gov details reveal that this trial, initially posted on June 30th 2022, is actively recruiting participants. To ensure successful completion of the study 1000 volunteers are needed from 5 different medical facilities."
Answered by AI
Is participation in the trial limited to individuals under 45 years old?
"This medical research is searching for participants who are between 18 and 70 years old."
Answered by AI
How extensive is the geographical coverage of this research endeavor?
"Patients can choose from 5 different clinical trial sites, including Atrium Health Wake Forest Baptist Weight Management Center in Winston-Salem, Johns Hopkins Medicine - Green Spring Station in Lutherville, and Kaiser Permanente Southern California in Los Angeles. Additionally, there are two other locations to select from."
Answered by AI
What are the common applications of Phentermine Hydrochloride 8 MG?
"Phentermine Hydrochloride 8 MG is an effective remedy for individuals with lipidemia, a body mass index over 27 kg/m2, and needing to reduce their weight."
Answered by AI
Are there any analogous research studies that have been conducted with Phentermine Hydrochloride 8 MG?
"Phentermine Hydrochloride 8 MG was first tested at Mayo Clinic in Rochester, USA during 2017. Since then, the drug has been studied extensively; there are 31 completed trials and 7 more ongoing ones happening primarily in Winston-Salem."
Answered by AI
Could I be eligible for involvement in this clinical trial?
"To be eligible for this medical trial, patients must present with obesity and meet the age criteria of between 18 to 70. The team is currently recruiting approximately 1000 participants."
Answered by AI
Does this clinical trial have open enrollment?
"Affirmative. According to clinicaltrials.gov, this research investigation is currently recruiting subjects and was initially posted on June 30th 2022. This data has been recently updated October 24th 2022 and the study seeks 1000 volunteers from 5 sites in total."
Answered by AI
Can one expect any deleterious effects from taking Phentermine Hydrochloride 8 MG?
"Phentermine Hydrochloride 8 MG is a well-established treatment, so it received the highest rating of 3 on our safety scale."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Other
California
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Other
Atrium Health Wake Forest Baptist Weight Management Center
UT Center for Obesity Medicine and Metabolic Performance
Kaiser Permanente Southern California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
1
0
Why did patients apply to this trial?
I need to lose weight. Seeking help in losing weight. I want to lose weight at least 30 lbs.
PatientReceived no prior treatments
i like to loose weight and keep it off. I tried 2 medications, phentermine and.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long do screening visits take? Can I still do the study if I have tried phentermine?
PatientReceived 2+ prior treatments
How many visits happen during the screening and during the trial. Are all visits onsite?
PatientReceived no prior treatments
Is there any monetary compensation for time and travel? Would this be available to us after the trials?
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Atrium Health Wake Forest Baptist Weight Management Center: < 24 hours
- HealthPartners Institute: < 48 hours
Average response time
- < 1 Day
Typically responds via
Phone Call
Email
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger