Phentermine for Obesity
(LEAP Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byNicholas M Pajewski, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Wake Forest University Health Sciences

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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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.

See 33 more

Treatment Details

Interventions

Online Lifestyle Behavioral Therapy (Behavioral Intervention)
Phentermine Hydrochloride 8 MG (Sympathomimetic Appetite Suppressant)

Trial OverviewThe 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.

Participant Groups

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.