Clinical trial success rates of anti-obesity agents: the importance of combination therapies

Obes Rev. 2015 Sep;16(9):707-14. doi: 10.1111/obr.12299. Epub 2015 Jul 29.

Abstract

The objective of this study was to construct a clinical trial profile assessing the risk of drug failure among anti-obesity agents. Research was conducted by looking at anti-obesity therapies currently on the market or in clinical trials (phases I to III) conducted from 1998 to September 2014, with the exclusion of any drugs whose phase I trial was conducted prior to January 1998. This was completed primarily through a search on http://clinicaltrials.gov where a total of 51 drugs met the search criteria. The transition probabilities were then calculated based on various classifications and compared against industry standards. The transition probability of anti-obesity agents was 8.50% whereas the transition probability of industry standards was 10.40%. Combination therapies had four times the transition probability than monotherapies, 40% and 4.75%, respectively. Therefore, it was determined that 92% of drugs fail during clinical trial testing for this indication and combination therapy appears to improve clinical trial success rates to 10-fold.

Keywords: Anti-obesity agents; clinical trials; combination therapies.

Publication types

  • Review

MeSH terms

  • Anti-Obesity Agents / administration & dosage*
  • Anti-Obesity Agents / pharmacology
  • Clinical Trials, Phase I as Topic
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Drug Design
  • Drug Therapy, Combination
  • Humans
  • Obesity / complications
  • Obesity / drug therapy
  • Obesity / prevention & control*
  • Treatment Failure

Substances

  • Anti-Obesity Agents