Medications for obesity have been studied in various populations over the past three decades. We aimed to quantify the baseline demographic characteristics of BMI, sex, age, and race in randomised clinical trials (RCTs) across three decades to establish whether the population studied is representative of the global population affected by the disease. Clinical trials of 12 medications for obesity (ie, orlistat, naltrexone–bupropion, topiramate–phentermine, liraglutide, semaglutide, lorcaserin, sibutramine, rimonabant, taranabant, tirzepatide, retatrutide, and orforglipron) published from Jan 20, 1999, to Nov 12, 2023, were assessed through a systematic review for methodological quality and baseline demographic characteristics. 246 RCTs were included, involving 139 566 participants with or without type 2 diabetes. Most trials over-recruited White, female participants aged 40 years or older with class 1 (30·0–34·9 kg/m) and class 2 (35·0–39·9 kg/m) obesity; older participants, those with class 3 (≥40·0 kg/m) obesity, non-White participants, and male participants were under-recruited. Our systematic review suggests that future trials need to recruit traditionally under-represented populations to allow for accurate measures of efficacy of medications for obesity, enabling more informed decisions by clinicians. It is also hoped that these data will help to refine trial recruitment strategies to ensure that future studies are relevant to the population affected by obesity.

中文翻译：

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过去三十年肥胖药物临床试验中的性别、种族和体重指数：系统评价


过去三十年来，人们对不同人群的肥胖药物进行了研究。我们的目标是量化三十年来随机临床试验 (RCT) 中的 BMI、性别、年龄和种族等基线人口特征，以确定所研究的人群是否能够代表受该疾病影响的全球人群。 1999年1月20日至11月12日发表的12种肥胖药物（即奥利司他、纳曲酮-安非他酮、托吡酯-芬特明、利拉鲁肽、司马鲁肽、氯卡色林、西布曲明、利莫那班、塔拉那班、替泽帕肽、瑞他鲁肽和奥福格列隆）的临床试验， 2023 年，通过对方法质量和基线人口特征的系统审查进行了评估。纳入 246 项随机对照试验，涉及 139 566 名患有或不患有 2 型糖尿病的参与者。大多数试验过度招募了 40 岁或以上的 1 级（30·0–34·9 kg/m）和 2 级（35·0–39·9 kg/m）肥胖的白人女性参与者；老年参与者、3级（≥40·0 kg/m）肥胖者、非白人参与者和男性参与者招募不足。我们的系统评价表明，未来的试验需要招募传统上代表性不足的人群，以便准确测量肥胖药物的疗效，从而使临床医生能够做出更明智的决策。人们还希望这些数据将有助于完善试验招募策略，以确保未来的研究与受肥胖影响的人群相关。