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Oracle Runs

Oracle findings and outcome history for A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity (NCT06046443).

Runs
1
Findings
1
Latest Run
Apr 1, 2026, 7:06 PM
Resolution Evidence
Outcome
YES
Status
Resolved
Settlement Date
4/1/26 UTC
Executive Summary

Rhythm publicly reported positive topline results for this exact Phase 2 trial of bivamelagon (formerly LB54640) in acquired hypothalamic obesity, stating it achieved statistically significant, clinically meaningful BMI reductions at Week 14 and planned End-of-Phase 2 regulatory interactions.

Sources
Sponsorir.rhythmtx.com7/9/25
Rhythm Pharmaceuticals Announces Oral MC4R Agonist Bivamelagon Achieved Statistically Significant, Clinically Meaningful BMI Reductions in Placebo-controlled Phase 2 Trial in Acquired Hypothalamic Obesity

Sponsor said this Phase 2 trial of bivamelagon, formerly LB54640, in acquired hypothalamic obesity had positive topline results and achieved statistically significant, clinically meaningful BMI reductions at 14 weeks.

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All Oracle Findings

Every stored oracle finding for this trial, including pending, dismissed, rejected, superseded, and accepted items.

YESAccepted97% confidenceGPT-5.4 (OpenAI)

Will the results be positive?

Rhythm publicly reported positive topline results for this exact Phase 2 trial of bivamelagon (formerly LB54640) in acquired hypothalamic obesity, stating it achieved statistically significant, clinically meaningful BMI reductions at Week 14 and planned End-of-Phase 2 regulatory interactions.

Found Apr 1, 2026, 7:06 PMOutcome date Jul 9, 2025, 12:00 AMReviewed Apr 1, 2026, 7:16 PM
Sponsorir.rhythmtx.comJul 9, 2025, 12:00 AM
Rhythm Pharmaceuticals Announces Oral MC4R Agonist Bivamelagon Achieved Statistically Significant, Clinically Meaningful BMI Reductions in Placebo-controlled Phase 2 Trial in Acquired Hypothalamic Obesity
Sponsor said this Phase 2 trial of bivamelagon, formerly LB54640, in acquired hypothalamic obesity had positive topline results and achieved statistically significant, clinically meaningful BMI reductions at 14 weeks.
Outcome History

Public history of accepted oracle reviews and recorded outcome changes for this trial.

Accepted Oracle Review (Legacy)Apr 1, 2026, 7:16 PM

Will the results be positive?

PendingtoYEScurrentYES
GPT-5.4 (OpenAI)97% confidenceReviewed Apr 1, 2026, 7:16 PM

Rhythm publicly reported positive topline results for this exact Phase 2 trial of bivamelagon (formerly LB54640) in acquired hypothalamic obesity, stating it achieved statistically significant, clinically meaningful BMI reductions at Week 14 and planned End-of-Phase 2 regulatory interactions.