Comparing Different Medication Regimens to Maintaining Weight Loss Among Adults With Obesity Using GLP-1s (OFF-RAMP)
OFF-RAMP Feasibility: a Pilot Trial Comparing Different Off-ramping Strategies for Maintaining Weight Loss Among Adults Using Incretin Based Therapies for Obesity
The purpose of this research is to compare weight loss among 3 groups:
- people who stay on a GLP-1 drug at full strength (Group 1)
- people who have their dose tapered to every other week, meaning slowly decreasing the dose and frequency of the full prescription you are currently taking (Group 2)
- people who go off their GLP-1 and instead take an alternative weight loss drug or combination of drugs called phentermine & topiramate. These are not GLP-1 medications. (Group 3)
The investigators want to see if the second and third options are effective at weight loss maintenance.
This study will include a total of 60 participants. Participants will be randomly assigned to one of the three study groups.
The goals of this current study are to:
- determine the acceptability of these proposed treatment strategies,
- collect data about how people's weight changes early on and throughout the study and how well people tolerate the medications.
- determine whether it is feasible to recruit for a larger, follow-up study.
There are 3 on-site visits: at the start, and then 6 and 12 months. The study team will do monthly phone calls in between those visits. At the on-site visits the study team will do various physical measures and collect blood for lab testing and provide participants with counseling to help with weight loss.
The study team will instruct participants in a home-based resistance exercise regimen to help maintain muscle mass. This will include exercises such as: sit-to-stand, mini-squats, calf raises, leg extension, wall press-up, and bicep curls two to three times a week. If these exercises are deemed too easy, participants may choose to do regular pushups, planks, lunges and/or add a resistance band.
Studienübersicht
Status
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 4
Kontakte und Standorte
Studienkontakt
- Name: Jing Luo, MD
- Telefonnummer: 412-383-3559
- E-Mail: luoj@pitt.edu
Studienorte
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15232
- University of Pittsburgh
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Kontakt:
- Jing Luo, MD
- Telefonnummer: 412-383-3559
- E-Mail: luoj@pitt.edu
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Participant Inclusion Criteria:
- Aged 18 years or older.
- Able to provide informed consent.
- Pre-treatment diagnosis of obesity (BMI≥30kg/m2).
- On a high potency GLP-1 based therapy (defined as semaglutide ≥1.7 mg or tirzepatide≥10mg).
- Has achieved, or are close to achieving, a "target body weight." Target body weight will be defined by each individual patient through self-report or their treating clinician but should generally be at least 5% below their weight prior to first starting GLP-1 based therapy.
- Has been on an incretin-based weight loss therapy for at least 6 months.
Participant Exclusion Criteria:
- Diagnosis of type 2 diabetes or pre-existing cardiovascular disease.
- Pregnancy or nursing or are seeking to become pregnant in the next year.
- Have had bariatric surgery.
- Unwilling to reduce the dose of their GLP-1 medication for weight loss, or who are unwilling to switch to another non-GLP-1based weight loss medication.
- Contraindications to phentermine: pre-existing cardiac arrhythmias, primary pulmonary hypertension, serious cardiac valvular disease, CAD, CVA, CHF, uncontrolled hypertension.
- Contraindications to bupropion/naltrexone: chronic opioid use, seizure disorders, use of other bupropion containing products, uncontrolled hypertension, monoamine oxidase inhibitors.
- Hyperthyroidism.
- Glaucoma, or at risk for glaucoma.
- History of substance use disorder.
- History of suicidal ideation.
- Concomitant monoamine oxidase inhibitors within 14 days.
- Use of lithium.
- Use of metformin.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Usual care
Maintenance of high-potency GLP-1 based therapy. Participants will continue their dose at enrollment for the entire duration of study follow-up. This is the current standard of care when the medication is covered and available. |
Participants in this arm will maintain their high-potency GLP-1 dosage. All participants will be recommended to do a "low touch" home-based resistance exercise regimen. These strength exercises will include: sit-to-stand, mini-squats, calf raises, leg extension, wall press-up, bicep curls two to three times a week. If too easy for a particular subject, the study may recommend regular push ups, planks, lunges and/or add a resistance band. Participants will be provided with guideline concordant weight loss maintenance education and counseling (i.e., calorie restriction, amount and intensity of physical activity, self-monitoring of weight, and measuring portion sizes). |
|
Experimental: Low dose, alternate frequency
GLP-1 dose reduction to lower-dose, alternate frequency. Participants on semaglutide at enrollment will gradually reduce their dose from 2.4mg to 1.7mg to 1.0mg to 0.5mg once a week to 0.5mg every other week. Participants on tirzepatide at baseline will gradually reduce their dose from 15mg to 12.5mg to 10mg to 7.5mg to 5mg once a week to 5mg every other week. Dose reductions are scheduled every 4 weeks. |
All participants will be recommended to do a "low touch" home-based resistance exercise regimen. These strength exercises will include: sit-to-stand, mini-squats, calf raises, leg extension, wall press-up, bicep curls two to three times a week. If too easy for a particular subject, the study may recommend regular push ups, planks, lunges and/or add a resistance band. Participants will be provided with guideline concordant weight loss maintenance education and counseling (i.e., calorie restriction, amount and intensity of physical activity, self-monitoring of weight, and measuring portion sizes). Participants in this intervention arm will receive a reduced GLP-1 dose compared to usual care. |
|
Experimental: Non-incretin based therapy
After gradually reducing GLP-1 therapy, participants will start phentermine with topiramate. Participants will reduce their semaglutide or tirzepatide dosage following the schedule of the "low dose, alternate frequency" arm until either semaglutide is 0.5mg once a week or tirzepatide is 5mg once a week. Participants will then start phentermine at 15mg once a day. Four weeks later, they will add topiramate at 25mg once a day. Four weeks later, they will increase the phentermine dose to 30mg once a day. Four weeks later, they will increase topiramate to 50mg once a day. Participants who cannot tolerate or have contraindications to phentermine will be offered bupropion + naltrexone. Dosages for bupropion would start at 75mg twice a day (maintenance dose 150mg twice a day). Dosages for naltrexone would start at 25mg per day. For subjects where a review by the PI or Co-I suggest a favorable benefit/risk profile, an option would be provided to increase naltrexone to 25mg twice per day. |
All participants will be recommended to do a "low touch" home-based resistance exercise regimen. These strength exercises will include: sit-to-stand, mini-squats, calf raises, leg extension, wall press-up, bicep curls two to three times a week. If too easy for a particular subject, the study may recommend regular push ups, planks, lunges and/or add a resistance band. Participants will be provided with guideline concordant weight loss maintenance education and counseling (i.e., calorie restriction, amount and intensity of physical activity, self-monitoring of weight, and measuring portion sizes). Participants in this intervention arm will be switched to a non-GLP weight loss medication. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Feasibility of recruitment and retention
Zeitfenster: Completion of participation, up to 12 months.
|
The primary study endpoint is feasibility. This trial will be considered feasible if the study achieves:
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Completion of participation, up to 12 months.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Acceptability of lower-dose, alternate frequency dosing or switching to non-incretin based weight loss therapy
Zeitfenster: 6-month study visit
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Acceptability of the individual comparators will be based on participant responses to a survey questionnaire developed for this study. The proposed comparators will be considered acceptable if at the 6-month study visit:
|
6-month study visit
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Feasibility of measuring percent change in body weight during follow-up
Zeitfenster: 6-month study visit
|
The study team will consider this feasible if ≥80% of participants have a valid, non-missing body weight measurement from the electronic health record in the 4-week window centered around the 6-month study visit. |
6-month study visit
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jing Luo, MD, University of Pittsburgh
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STUDY26060140
- 1R01DK148666 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
De-identified individual participant level data generated from the PI's institution (UPMC) will be shared to eligible individuals by request in writing to the PI and through deposit in Zenodo (see below). Data sharing at the de-identified individual level will be sufficient to replicate the study results. These data made available must be under terms and conditions consistent with the informed consent provided by individual participants, and as approved by the awardees' Institutional Review Board (IRB) and any local, state and Federal laws and regulations
IPD-Sharing-Zeitrahmen
Data may be made available at the end of the performance period, or time of an associated publication. It will be available for up to 5 years.
IPD-Sharing-Zugriffskriterien
Anyone in the general public can search and identify data on Zenodo's website. Data will be made available by a data repository only after approval. Data from this trial (deidentified individual participant data) will be restricted to medical professionals who submit a data access request.
Arzneimittel- und Geräteinformationen, Studienunterlagen
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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