Long-term Effectiveness of the Antiobesity Medication Phentermine

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

870

Participants

Timeline

Start Date

June 30, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
ObesityObesity; DrugLifestyle, Healthy
Interventions
BEHAVIORAL

Online Lifestyle Behavioral Therapy

Participants will receive access to the WW™ digital application for the duration of their participation. The WW™ digital application can be accessed using a smartphone, tablet or personal computer and includes functions such as food journaling, progress charts, lifestyle coaching , ability to manually enter exercise data or link with a fitness tracking device, incentives for behavior change, recipes, and local restaurant recommendations using GPS. Over the course of 12 clinic visits with an obesity provider, participants will be prescribed a dietary plan based on the WW™ app and will be asked to journal dietary intake.

DRUG

Phentermine Hydrochloride 8 MG

At the randomization visit, participants will be started on 8 mg PO daily of phentermine or placebo, with a recommendation to take the medication in the morning. They will be provided with detailed instructions on how to increase their dose of study drug over the subsequent weeks. After one week, participants will increase to 16 mg daily. After the second week, participants will further increase their dose to 24 mg daily and at the 1-month in-person follow-up, participants who tolerate the 24 mg dose will be maintained on this as the maximum daily dose for a total of 24 months. For participants who do not tolerate an escalation in medication dose due to side effects, adverse events, and/or elevations in blood pressure and/or heart rate, the study clinician may adjust the dose and/or delay dose escalation. Study clinicians will work with participants to achieve and sustain the maximum dose tolerated.

Trial Locations (4)

27104

Atrium Health Wake Forest Baptist Weight Management Center, Winston-Salem

55416

HealthPartners Institute, Saint Louis Park

77401

UT Center for Obesity Medicine and Metabolic Performance, Bellaire

90034

Kaiser Permanente Southern California, Los Angeles

All Listed Sponsors
collaborator

Johns Hopkins University

OTHER

collaborator

Kaiser Permanente

OTHER

collaborator

HealthPartners Institute

OTHER

collaborator

The University of Texas Health Science Center, Houston

OTHER

collaborator

Biomedical Research Institute of New Mexico

OTHER

collaborator

WW International Inc

INDUSTRY

collaborator

KVK-Tech, Inc.

UNKNOWN

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Wake Forest University Health Sciences

OTHER