Use of Medication to Improve Weight Loss in Suboptimal Early Responders to Behavioral Treatment

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a two-phase study. Phase 1 will evaluate obesity-related behavioral and biological characteristics as potential predictors of response to behavioral treatment (BT) for weight loss. Phase 2 is a double-blind, placebo-controlled, RCT to test whether adding weight loss medication to BT improves 24-week weight loss, as compared to BT with placebo, in subjects identified as having suboptimal early weight loss after 4 weeks of individual behavioral weight control. All participants, regardless of their early weight loss, will receive the same BT program of diet, physical activity, and behavior therapy for weight loss for an additional 24 weeks (28 total weeks of treatment).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Liraglutide; Phentermine

Criteria

Inclusion Criteria:

1. BMI ≥ 31 kg/m² (or 28 kg/m2 with obesity-related comorbidity)

2. Age ≥ 21 years and ≤ 70 years

3. Eligible female patients will be:

• non-pregnant, evidenced by a negative urine pregnancy test

• non-lactating

• surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study. Acceptable methods of birth control are: hormonal contraceptives; double barrier method (condom with spermicide or diaphragm with spermicide); intrauterine device; surgical sterility; abstinence; and/or postmenopausal status (defined as at least 2 years without menses).

4. Subjects must:

• have a primary care provider (PCP) who is responsible for providing routine care

• understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent

• plan to remain in the Philadelphia area for the next 9 months or more

Exclusion Criteria:

1. Pregnant or nursing, or plans to become pregnant in the next 9 months.

2. Uncontrolled hypertension (systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg)

3. Type 1 diabetes

4. Type 2 diabetes

5. A fasting blood glucose > 126 mg/dL (on second assessment after first elevated value)

6. History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, or heart block greater than first degree

7. Clinically significant hepatic or renal disease

8. Hyperthyroidism

9. Other thyroid disease, not controlled

10. History of malignancy (except for non-melanoma skin cancer) in past 5 years

11. Narrow angle glaucoma

12. Presence or history of marked agitation

13. Current severe major depressive episode (BDI-II score ≥ 29), current active suicidal ideation, or history of suicide attempts within the past 5 years.

14. Any severity of thought or bipolar disorder, or bulimia nervosa.

15. Psychiatric hospitalization within the past 6 months

16. Self-reported alcohol or substance abuse within the past 6 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)

17. Past year history of drug abuse

18. Use in the past 2 weeks of monoamine oxidase inhibitors

19. Current use of serotonin-norepinephrine reuptake inhibitors (SNRIs; e.g. venlafaxine, duloxetine, desvenlafaxine, milnacipran, levomilnacipran).

20. Use in past 6 months of medications known to induce significant weight loss (i.e., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)

21. Loss of ≥ 5% of initial body weight within the past 6 months

22. History of (or plans for) bariatric surgery (e.g., roux en y gastric bypass, sleeve gastrectomy, gastric banding), endoscopic intragastric balloon, or aspire assist.

23. Inability to walk 5 blocks comfortably or engage in some other form of aerobic activity (e.g., swimming)

24. Known or suspected allergy to sympathomimetic amines or related products

25. The receipt of any investigational drug within 6 months prior to this trial

26. Previous participation in this trial (e.g., randomized and failed to participate)

27. Changes to any chronic medication (type or dosage) within the past 3 months.

28. Any serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study

Other Therapy: Subjects will be expected to use medications (prescribed by their PCP) to control traditional cardiometabolic risk factors (e.g., hypertension, hypercholesterolemia, etc) and other co-morbid conditions, with the exception of medications listed above under "exclusions." In all cases, the subjects' PCP will be asked at the study's outset to keep medication does constant throughout the study, whenever possible. Subjects will be expected to have been on their medication regimen (including the dose) for 3 months prior to beginning the BT program.

To be eligible to participate in the randomized phase of the trial, subjects must also:

1. Complete at least 3 out of 4 treatment sessions during the 4-week BT run-in and attend a randomization visit. Attending an in-person makeup session within one week of a missed visit will count as having attended the run-in visit.

2. Lose < 2.0% of initial weight during the 4-week BT run-in.

Early BT responders who lose>=2% during the BT run-in will be offered the same 24-week BT program, but will not receive study medication or be included in the randomized trial.