The GLP-1 PR has been a little too good.<\/p>\n
Everyone knows the drugs lead to rapid weight loss<\/a> \u2014 including participants in supposedly \u201cblind\u201d drug trials. So now, when those participants don\u2019t drop pounds, they drop out.<\/p>\n Pharmaceutical manufacturers are reporting widespread instances of patients quitting their clinical trials prematurely once they realize they\u2019ve been assigned a placebo instead of the real thing, raising questions about how trials for obesity drugs should be run moving forward.<\/p>\n The popularity of certain weight-loss drugs, like Wegovy, may force pharma companies to restructure their clinical trials for new, emerging obesity drugs. Road Red Runner \u2013 stock.adobe.com<\/p>\n Raymond Stevens, CEO of Structure Therapeutics Inc., confirmed to Bloomberg<\/a> that \u201cpeople learn pretty quickly whether they\u2019re on placebo or not.\u201d It\u2019s made conducting clinical trials for Structure\u2019s experimental weight loss pill \u201ca challenge.\u201d<\/p>\n Many people who opt into these clinical trials are looking for solutions to their health problems. When they don\u2019t get the results they want \u2014\u00a0or, in the case of GLP-1s, the results they\u2019ve come to expect \u2014 they feel they\u2019ve wasted precious time that could have been spent getting healthier.<\/p>\n Bloomberg spoke with a 57-year-old New England\u2013based clinical trial participant who gave his name as Tom. He said he stayed on a study for Eli Lilly & Co.\u2019s new retatrutide<\/a> shot because he didn\u2019t think he could get Wegovy or Zepbound through his insurance.<\/p>\n Tom, who survived a heart attack over a decade earlier, lost 45 pounds in less than a year at the start of the trial. But when he didn\u2019t experience any side effects like nausea or vomiting<\/a>, he had a gut feeling that the changes weren\u2019t due to the drug.<\/p>\n \u201cI could tell the only reason I was dropping [the weight] was because I was being really vigilant about the diet,\u201d he said. \u201cMy appetite was still 100% the same. Over time, my weight drifted back up again, and it became pretty clear I was on the placebo.\u201d<\/p>\n If he can get his insurance to cover Wegovy \u2014 which he might be able to do, under the premise that it helps protect against heart disease \u2014 he said he would leave the retatrutide study.<\/p>\n Orforglipron and retatrutide, a pill and shot respectively, are just two of hundreds of new weight-loss drugs under development around the world. lecic \u2013 stock.adobe.com<\/p>\n Social media hasn\u2019t helped pharma companies retain trial patients, either.<\/p>\n Some participants have been posting<\/a> about their trial experiences with Eli Lilly\u2019s new pill, orforglipron<\/a>.\u00a0<\/p>\n \u201cPeople aren\u2019t supposed to be talking about these things, but it was on Reddit \u2014 during the trial,\u201d Stevens told Bloomberg.<\/p>\n And Eli Lilly is feeling the heat: A spokesperson told Bloomberg that in a major orforglipron trial, 6.2% of placebo patients quit because they were unhappy with their weight loss, and 2.5% sought other ways to drop pounds, which sometimes meant they took different obesity medications.<\/p>\n That\u2019s not allowed, the spokesperson said, but participants could stay in the trial as long as they quit the study drug.<\/p>\n With hundreds of weight-loss drugs in the experimental phase at any given time \u2014 and with trillions of dollars at stake<\/a> \u2014 these companies share a growing appetite for a restructured clinical trial process that would better account for these flukes, especially because skewed results could make their drugs look less effective. <\/p>\n Swiss pharma giant Roche Holding has emerged as a major contender in the obesity and GLP-1 market. SOPA Images\/LightRocket via Getty Images<\/p>\n Swiss drugmaker Roche Holding AG, for example, already made some changes. The plan is to offer patients a \u201clong-term extension period\u201d for their trials, giving whoever receives the placebo a chance to then switch and take the experimental drug.\u00a0<\/p>\n