Your session is about to expire
← Back to Search
Sympathomimetic Appetite Suppressant
Phentermine for Obesity (LEAP Trial)
Phase 4
Waitlist Available
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
Must not have
History of glaucoma or been told by an ophthalmologist that you are at high risk for glaucoma
Diagnosis of dementia or serious mental illness (e.g., schizophrenia, bipolar disorder, severe depression)
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
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial is studying the long-term effects of the weight-loss drug phentermine on people with obesity. The drug helps by making you feel less hungry and burning more calories. Researchers want to see if it is safe and effective over an extended period. Phentermine has been used in various formulations and combinations for weight loss, showing modest efficacy but with potential cardiovascular and psychiatric side effects.
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have glaucoma or am at high risk for it.
Select...
I have been diagnosed with dementia or a serious mental illness.
Select...
I have not used any monoamine oxidase inhibitors in the last 14 days.
Select...
I have a history of heart or blood vessel diseases.
Select...
I have anxiety symptoms that are not well-managed.
Select...
I have severe kidney disease or am on dialysis.
Select...
I have undergone a procedure to help control my weight.
Select...
I have had an organ transplant.
Select...
My blood pressure is high or my heart beats very fast.
Select...
I have not had heavy alcohol use in the last 6 months.
Select...
I have not had any cancer except for non-melanoma skin cancer in the last 5 years.
Select...
My weight has changed by more than 5% in the last 3 months.
Select...
I have used oral corticosteroids for more than 5 days a month in the last 3 months.
Select...
I need extra oxygen due to severe lung problems.
Select...
I have a history of heart valve disease.
Select...
I have a history of irregular heartbeats.
Select...
I am currently being treated for an overactive thyroid.
Select...
I have a history of or currently have congestive heart failure.
Select...
I have not had cirrhosis or symptoms of liver failure in the last 2 years.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in Systolic Blood Pressure (mmHg)
Change in cardiac autonomic function
Change in resting energy expenditure (REE) / resting metabolic rate (RMR)
+1 moreOther study objectives
Change in body weight (%)
Change in self-reported physical activity levels
Incident cardiovascular disease or death
Awards & Highlights
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.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for obesity often involve medications that act as appetite suppressants by stimulating the central nervous system, such as phentermine. These drugs increase the release of norepinephrine, which reduces hunger and increases energy expenditure.
Other treatments include GLP-1 receptor agonists, which enhance insulin secretion and slow gastric emptying, leading to reduced appetite and food intake. These mechanisms are crucial for obesity patients as they help in reducing caloric intake and promoting weight loss, which can improve overall health and reduce the risk of obesity-related complications.
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
WW International IncIndustry Sponsor
23 Previous Clinical Trials
4,261 Total Patients Enrolled
12 Trials studying Obesity
2,450 Patients Enrolled for Obesity
The University of Texas Health Science Center, HoustonOTHER
950 Previous Clinical Trials
344,175 Total Patients Enrolled
28 Trials studying Obesity
14,430 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
Share this study with friends
Copy Link
Messenger