Regulatory frame
FDA's January 2025 draft guidance remains centered on sustained body-weight reduction and maintenance. Visceral-fat reduction is a differentiation signal, not yet the regulatory anchor.
Obesity benchmark
Visceral-fat benchmarks for obesity programs where total body-weight loss is not the whole development thesis.
Regulatory frame
FDA's January 2025 draft guidance remains centered on sustained body-weight reduction and maintenance. Visceral-fat reduction is a differentiation signal, not yet the regulatory anchor.
Comparison metric
The chart uses placebo-adjusted visceral-fat reduction where available. Absolute-only values stay as context rather than entering the benchmark.
Clinical read
The investor question is whether fat-distribution biology can support add-on, maintenance, MASH-adjacent, or cardiometabolic-risk positioning beyond total weight loss.
Sources: FDA January 2025 draft obesity guidance; Wave INLIGHT 6-month Phase 1 update; Arrowhead January 2026 ARO-INHBE / ARO-ALK7 interim update; Arrowhead May 2026 ARO-INHBE EASL update; SURMOUNT-1 and STEP 1 body-composition substudies.
Results measure different aspects of body composition. Cross-trial comparisons do not establish overall clinical benefit. Disclosures
Body-composition landscape
This view compares placebo-adjusted visceral-fat reduction where reported. Tirzepatide is included as an approved incretin anchor; semaglutide is not charted because the clean published value is absolute rather than adjusted.
Chart uses placebo-adjusted visceral-fat reduction where available. Values are not duration-, imaging-, or population-normalized and should not be interpreted as regulatory efficacy endpoints.
Upcoming catalysts
The next readouts need to show whether visceral-fat reduction is durable, clinically interpretable, and useful alongside incretin therapy.
Wave Life Sciences
INHBE silencing program
The Phase 1 signal is a body-composition signal, not a weight-loss ranking. Higher-BMI Phase 2a data should clarify whether visceral-fat reduction scales with baseline adiposity and comorbidity burden.
Watch for: Visceral-fat change, total fat, lean-mass preservation, waist circumference, and whether body-weight change becomes meaningful in the higher-BMI cohort.
Arrowhead Pharmaceuticals
INHBE / Activin E RNAi program
ARO-INHBE has both visceral-fat and liver-fat signals. That makes the MASH-adjacent path important, but it also raises the bar for clean endpoint selection in obesity studies.
Watch for: Longer follow-up, liver-fat durability, visceral-fat durability, and whether Phase 2 design prioritizes obesity, MASH, or a defined cardiometabolic phenotype.
Arrowhead Pharmaceuticals
ACVR1C / ALK7 adipose RNAi program
ARO-ALK7 is the most direct adipose-targeted program in this group. The first question is durability; the second is whether target knockdown translates into clinical outcomes beyond an imaging endpoint.
Watch for: Multiple-dose visceral-fat data, repeated adipose target knockdown, combination data with tirzepatide, and any lean-mass or glycemic read-through.