Predictors of Lorcaserin-Induced Weight Loss

Summary

This two-phase study aims to explore ways to predict who will respond well to the weight loss drug lorcaserin and to understand the mechanisms that develop which limit drug efficacy. Subjects will be recruited for a 5-week crossover study (phase 1) with lorcaserin and placebo followed by treatment with lorcaserin for 24 weeks (phase 2).

Timeline

Start

2018-01-03

Primary completion

2020-02-14

Completion

2020-02-14

Outcome

Mixed primary results

Stopped: “The FDA advised of a possible health risk associated with lorcaserin and the drug is being withdrawn.”

registry MEAN Placebo: 919.8 (Standard Error 118.7) kcal NCT03353220 ↗

registry MEAN Lorcaserin: 891.9 (Standard Error 109.0) kcal NCT03353220 ↗

registry analysis (other test); Placebo vs Lorcaserin; p = 0.65; t-test, 2 sided; note: paired t test NCT03353220 ↗

registry MEAN Placebo: 256.9 (Standard Error 18.5) fmol/ml NCT03353220 ↗

registry MEAN Lorcaserin: 225.0 (Standard Error 15.9) fmol/ml NCT03353220 ↗

registry analysis (other test); Placebo vs Lorcaserin; p = 0.0001; t-test, 2 sided; note: paired t test NCT03353220 ↗

Publications

• Results Sideri Gugger A, Dimino C, Panigrahi SK, Mayer L, Smiley RM, Korner J, Wardlaw SL. Defining Predictors of Weight Loss Response to Lorcaserin. J Clin Endocrinol Metab. 2023 Aug 18;108(9):2262-2271. doi: 10.1210/clinem/dgad139.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belviq	Unknown	10 mg	Oral

Indications

No indication recorded.