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Can a 60-year-old diet pill work for years? new study aims to find out.

NCT ID NCT05176626

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the weight-loss drug phentermine, currently approved for only 12 weeks, can be safely used for up to 2 years. About 870 adults with obesity will take phentermine and receive online lifestyle coaching. Researchers will track weight loss, blood pressure, and other health measures to see if long-term use is effective and safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
phentermine
What this could lead to
If successful, this could show that phentermine is safe and effective for long-term weight management, supporting its use beyond the current 12-week limit.
What could go wrong
This is a Phase 4 trial, but phentermine has known risks like increased blood pressure and heart rate. Long-term safety data are still limited, and weight loss may not be sustained in all participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

870 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) * English-speaking * Has a smartphone or other device with regular internet access * Interested in and willing to lose weight as a result of treatment * Able to take oral medication and willing to adhere to the clinical visit schedule for the trial and lifestyle based treatment regimen throughout the study duration, as recommended by the study clinician * For females of reproductive potential: use of effective contraception for at least 1 month prior to randomization and agreement to use such a method during study participation and for an additional 8 weeks after the end of study drug administration * Provision of electronically-signed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * History of coronary artery, cerebrovascular or peripheral arterial disease including myocardial infarction, unstable angina, revascularization, stroke/TIA, carotid intervention, claudication * Poorly-controlled blood pressure (\>149/94) or elevated heart rate (\>110 bpm) * History of cardiac arrhythmia * Active / currently-treated hyperthyroidism * History of glaucoma or been told by an ophthalmologist that you are at high risk for glaucoma * Heavy alcohol use within the last 6 months (men: more than 4 drinks on any day or more than 14 drinks per week; women: more than 3 drinks on any day or more than 7 drinks per week) * History of substance use disorder or active use of illicit substances within the last 12 months. Tetrahydrocannabinol (THC)-containing products will not be considered an illicit substance. * Use of a drug in the monoamine oxidase inhibitor class, currently or within the last 14 days * Currently pregnant or lactating/breastfeeding; intention to get pregnant in next 24 months; seeking or in active treatment for infertility * End-stage renal disease on dialysis or CKD class IV or higher (eGFR \<30) * History of valvular heart disease * Congestive heart failure (any history or current) * Cirrhosis or symptoms of liver failure in the last 2 years * Severe pulmonary disease requiring supplemental oxygen * Quit using nicotine-containing products less than 6 months prior to baseline visit or intention to quit use in the next 2 years * Use of oral corticosteroids more than 5 days/month in the last 3 months * Elevated depressive symptoms * Uncontrolled anxiety symptoms * Hospitalization for mental illness in the last 24 months * Diagnosis of dementia or serious mental illness (e.g., schizophrenia, bipolar disorder, severe depression) * Binge Eating Disorder, Bulimia or Anorexia Nervosa diagnosis or treatment within the last 2 years * Prior procedure for weight control (including bariatric surgery, devices) * Use of phentermine, phentermine-containing medication, or anti-obesity medication with similar mechanism of action to phentermine (e.g., phendimetrazine or diethylpropion) in the previous 24 months * Use of any non-phentermine-containing medications prescribed for weight loss in previous 12 months * Unstable dose of weight-loss-promoting medications within the last 12 months. Weight-loss-promoting medications are medication prescribed for another condition, but are known to have weight loss effects. Examples would include use of a GLP1 agonist or SGLT2 inhibitor in patients with diabetes; use of topiramate among patients with migraine headaches. * Use of any stimulant medications in previous 12 months * Known allergy or intolerance to phentermine or phentermine-containing medication * Documented or self-reported weight change (gain or loss) of more than 5% of current body weight in the past 3 months * History of cancer other than non-melanoma skin cancer in the past 5 years * History of organ transplantation * Plan to move outside the area in the next two years * Unable to make changes to diet (e.g., severe food allergies or intolerances; medically necessary aspects of diet incompatible with intervention) * Already participating in another research study that includes lifestyle changes and/or study medication or has participated in such a study within the last 12 months * Total body weight that exceeds 400 lbs., precluding use of the digital scale in the lifestyle intervention * Upper arm circumference that exceeds 50 cm, precluding use of the OMRON HEM 907 XL to measure blood pressure * Other concern or medical comorbidity that, per discretion of study clinician, would render the participant unfit or unable to safely take part in the 24-month intervention

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Atrium Health Wake Forest Baptist Weight Management Center

    Winston-Salem, North Carolina, 27104, United States

  • HealthPartners Institute

    Saint Louis Park, Minnesota, 55416, United States

  • Kaiser Permanente Southern California

    Los Angeles, California, 90034, United States

  • UT Center for Obesity Medicine and Metabolic Performance

    Bellaire, Texas, 77401, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.