Phentermine for Obesity
(LEAP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the long-term effects of using phentermine, a weight loss medication, for weight management. Although phentermine has been available for some time, it is typically used only for short durations. The study evaluates its safety and effectiveness when taken for up to two years, focusing on weight, blood pressure, and other health outcomes. Suitable participants have a BMI of 30 or higher, or a BMI between 27 and 29.9 with health issues such as high blood pressure or type 2 diabetes, and are interested in losing weight. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used certain weight-loss or stimulant medications in the past 12 months. It's best to discuss your specific medications with the study team.
What is the safety track record for phentermine hydrochloride?
Research shows that phentermine has been safely used for short-term weight loss. Studies have found that it can help people lose weight and reduce waist size without causing major side effects. However, phentermine is usually approved for short-term use, not long-term. This trial examines its effects over a longer period, which is new because the drug is typically taken for up to 12 weeks.
Phentermine has been available since 1959 and is approved by the FDA for short-term weight management. However, some safety concerns exist. It can be misused or abused, so careful use is necessary. Additionally, alcohol consumption is not recommended while taking phentermine due to possible risks.
In summary, phentermine is generally safe for short-term weight loss. This trial aims to understand its safety when used for a longer time.12345Why are researchers enthusiastic about this study treatment?
Phentermine is unique because it offers a lower dose option for treating obesity, using phentermine hydrochloride 8 mg tablets, which is marketed under the brand Lomaira. While traditional obesity treatments often include higher doses of phentermine or other medications like orlistat and liraglutide, this formulation provides a potentially safer and more accessible option by reducing side effects associated with higher dosages. Researchers are excited about phentermine because it could provide effective weight management with a lower risk of adverse effects, making it an appealing alternative for those who cannot tolerate higher doses.
What is the effectiveness track record for phentermine in treating obesity?
Research has shown that phentermine aids in weight loss. In one study, about 38% of participants taking 30 mg of phentermine lost between 5% and 10% of their body weight over a few months. Another study found that phentermine helped maintain weight loss even after six months. Additionally, when combined with topiramate, about 32% of participants lost 15% of their body weight. In this trial, participants will receive phentermine hydrochloride 8 mg to evaluate its long-term effects. Phentermine is approved by the FDA for short-term weight management, and this trial will explore its long-term effects.36789
Who Is on the Research Team?
Jamy Ard, MD
Principal Investigator
Wake Forest University Health Sciences
Kristina H Lewis, MD
Principal Investigator
Wake Forest University Health Sciences
Nicholas M Pajewski, PhD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 24 mg/day of phentermine or placebo for up to 24 months, with an evidence-based online lifestyle intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Online Lifestyle Behavioral Therapy
- Phentermine Hydrochloride 8 MG
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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 Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Weight Watchers International
Industry Sponsor
WW International Inc
Industry Sponsor
The University of Texas Health Science Center, Houston
Collaborator
Biomedical Research Institute of New Mexico
Collaborator
WW International Inc.
Collaborator
Kaiser Permanente
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
KVK-Tech, Inc.
Collaborator
Johns Hopkins University
Collaborator
Published Research Related to This Trial
Citations
Three- and six-month efficacy and safety of phentermine in ...
Data expressed as the number of patients (%). Regarding 30 mg of phentermine, it induced a body weight reduction between ≥ 5 and < 10% in 37.7% of non- ...
NCT05176626 | Long-term Effectiveness of the Antiobesity ...
The purpose of this research study is to understand the long-term effects of the drug phentermine on weight, blood pressure, other health outcomes, and safety.
Utilization of Low‐Dose Phentermine for Weight Loss Prior ...
In dietary intervention trials, patients typically achieve < 5% weight loss after 12 months [19]. In contrast, patients in this study assigned ...
Obesity pillars roundtable: Phentermine – Past, present, ...
If you look at the SEQUEL study [36] of phentermine and topiramate in Table 2, 32% of people were able to achieve 15% weight loss.
Effects on Weight Reduction and Safety of Short-Term ...
In this study, they reported that phentermine had held the effect of gradual loss in weight even after the 6 months of drug administration, which is different ...
Phentermine (oral route) - Side effects & dosage
Phentermine is used for weight reduction in patients with obesity. ... Safety and efficacy have not been established. Geriatric. Appropriate ...
Important Safety Information
Phentermine has the potential to be abused. Keep Lomaira in a safe place to prevent theft, accidental overdose, misuse or abuse. Using alcohol with phentermine ...
LOMAIRA™ (phentermine hydrochloride USP) tablets, CIV
Pediatric Use. Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long-term ...
Adipex-p (phentermine hydrochloride) capsules label
Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended.
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