drugset / Trial / NCT03779048

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

NCT03779048

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2019-07-15
Primary completion
2022-05-25
Completion
2022-05-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Phentermine Small molecule 15 mg Oral

Indications