Obesity Trial Cohort Demographics

Nephrobesity · Data supplement to the Obesity Medication Timeline

Who was studied before approval?

Demographic composition of the registration cohorts behind every FDA approval in obesity and incretin pharmacotherapy since 1996 — obesity and diabetes indications shown side by side. Built to answer a question from clinic: how closely did the trial population behind an approval resemble the patient in front of you? Every cell is drawn from a primary source: an FDA Drug Trials Snapshot, an FDA review, the label, or the pivotal trial’s own report. Values that could not be sourced are marked n.r. and were not estimated.
FDA Drug Trials Snapshot FDA review (clinical / statistical) Label §14 or trial registry no usable source

What the table shows

  • Black participants. Typically 4–11%, against a US obesity prevalence that is substantially higher in this group — and as low as 0.6% in the Alli trial. The exceptions run upward: Xenical 14%, Belviq 18.8%, Contrave 19.4%, Qsymia pediatric 26.9%.
  • Asian participants. Not reported at all in the orlistat-era reviews, below 1% in the 2012 approvals, 28% in ATTAIN-1 in 2026. The shift tracks where trial sites moved, not a change in US recruitment.
  • The 1990s cannot be reconstructed from FDA sources. For dexfenfluramine and sibutramine, no demographic composition of the registration trials appears in any FDA label or review; even the pivotal publications report little beyond enrollment.

Method and limitations

  • Source hierarchy per cell: FDA Drug Trials Snapshot, then FDA clinical or statistical review, then label §14 or the trial registry, then the primary publication. The tier actually used is marked in the Source column.
  • Where available, the randomized population is reported. Where a publication and an FDA document disagree, the FDA document governs.
  • Race categories are not harmonized across approvals. Some trials break out American Indian/Alaska Native, others do not, so rows are strictly comparable within themselves rather than down a column.
  • Where labels round to whole percentages, decimals were computed from the trial’s posted results on ClinicalTrials.gov (SELECT, FLOW, SURMOUNT-OSA, SCALE Teens).
  • “n.r.” means not retrievable from an acceptable primary source. Nothing was estimated, interpolated, or carried over from a sibling trial.
  • Every row was independently re-verified against the primary sources in August 2026, including recomputation of pooled percentages from per-arm counts.

Footnotes