Phentermine for Obesity

(LEAP Trial)

Not currently recruiting at 4 trial locations

Overseen By Amanda Velazquez, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Wake Forest University Health Sciences

Must not be taking: MAO inhibitors, Stimulants

Disqualifiers: Heart disease, Glaucoma, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

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. ^{1 2 3 4 5}

Why 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. ^{3 6 7 8 9}

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

Has a smartphone or other device with regular internet access

English-speaking

Provision of electronically-signed consent form

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 24 mg/day of phentermine or placebo for up to 24 months, with an evidence-based online lifestyle intervention

24 months

Monthly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

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?

Group I: Phentermine Experimental Treatment 2 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Weight Watchers International

Industry Sponsor

Trials

23

Recruited

5,100+

WW International Inc

Industry Sponsor

Trials

25

Recruited

5,300+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Biomedical Research Institute of New Mexico

Collaborator

Trials

11

Recruited

2,300+

WW International Inc.

Collaborator

Trials

5

Recruited

1,200+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

KVK-Tech, Inc.

Collaborator

Trials

1

Recruited

870+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

A comprehensive analysis of the FDA Adverse Event Reporting System revealed 18,675 unique adverse event reports linked to anti-obesity medications (AOMs) among 15,143 patients, highlighting significant safety concerns.

Serious adverse events included a fatality ratio of 4.9%, with cardiovascular complications being particularly prevalent, accounting for 31% of AEs related to phentermine, and indicating a need for ongoing safety monitoring of AOMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. Alsuhibani, A., Alrasheed, M., Gari, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8295716/

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- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05176626

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.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/osp4.70043

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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2667368122000158

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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2687747/

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 ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/phentermine-oral-route/description/drg-20075169

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 ...

7. lomaira.com lomaira.com/important-safety-information/

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 ...

8. fda.gov fda.gov/media/138795/download

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 ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf

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.