Comparing Different Medication Regimens to Maintaining Weight Loss Among Adults With Obesity Using GLP-1s
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorJing Luo
About this trial
The purpose of this research is to compare weight loss among 3 groups:
1. people who stay on a GLP-1 drug at full strength (Group 1) 2. 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) 3. 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:
1. determine the acceptability of these proposed treatment strategies, 2. collect data about how people's weight changes early on and throughout the study and how well people tolerate the medications. 3. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
GLP-1 dose reduction
DrugParticipants in this intervention arm will receive a reduced GLP-1 dose compared to usual care.
non-GLP weight loss medication
DrugParticipants in this intervention arm will be switched to a non-GLP weight loss medication.
Maintenance of GLP-1 dose
DrugParticipants in this arm will maintain their high-potency GLP-1 dosage.
Resistance exercise regimen
BehavioralAll 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.
Lifestyle/nutrition counseling
BehavioralParticipants 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).
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Usual careActive comparator 3 interventions
Group B: Low dose, alternate frequencyExperimental treatment 3 interventions
Group C: Non-incretin based therapyExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Feasibility of recruitment and retention
The primary study endpoint is feasibility. This trial will be considered feasible if the study achieves: * ≥60% consent to approach rate. * ≥80% enrolled to consent rate. * A total of at least 60 participants (20 per study arm). * ≥80% protocol completion rate among enrolled participants at 6 months. * ≥70% protocol completion rate among enrolled participants at 12 months.
Time frame
Completion of participation, up to 12 months.Secondary outcomes
1
Acceptability of lower-dose, alternate frequency dosing or switching to non-incretin based weight loss therapy
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: * ≥70% of patients would recomend the intervention to other patients using incretin based therapies for weight loss, OR * ≥70% of patients agree or strongly agree that the randomly assigned intervention has "helped me maintain me weight loss or level of function".
Time frame
6-month study visitOther outcomes
1
Feasibility of measuring percent change in body weight during follow-up
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.
Time frame
6-month study visitSponsors and contacts
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Jing Luo
Lead sponsor
University of Pittsburgh
Sponsor institution
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: