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Melanotan-2

MT-II, Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2

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Overview Studies Clinical Trials

Completed PHASE2 INTERVENTIONAL NCT05546476

Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.

Detailed Description

A 12 week double blind study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15. During the initial 12-week treatment period (Part A), a total of 3 doses of ponsegromab or placebo will be administered 4 weeks apart subcutaneously. Each dose contains two injections. Part B is an optional open-label treatment period consisting of ponsegromab administered every 4 weeks subcutaneously for up to one year. Part B does not include placebo. Assessments include: * Body weight measurements * Measure the impact of ponsegromab compared to placebo on physical activity. * Measure the impact of ponsegromab compared to placebo on appetite, fatigue, nausea, vomiting and physical function questionnaires. * Blood samples to evaluate safety and additional endpoints including the amount of study drug in the blood and the effects of the study drug on levels of GDF15 * Up to 3 additional blood samples (two samples during Part A and one sample during Part B, if relevant) in a subset of participants as part of a substudy for more comprehensive assessment of the amount of study drug in the blood and of the effects of the study drug on levels of GDF-15.

Interventions

Name: ponsegromab

Type: DRUG

Description: Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment

Name: Placebo for ponsegromab

Type: DRUG

Description: Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment

Primary Outcomes

Measure: Part A: Change From Baseline in Body Weight at Week 12

TimeFrame: Baseline, Week 12

Description: Body weight was measured in kilograms using a calibrated weighing scale. Baseline was defined as the last average of the duplicate measurements prior to, or on Day 1. The average of the duplicate body weights collected at assessment time was considered. The posterior medians and 90 percent (%) credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for each randomized dose (including placebo). 4-Parameter maximal effect (E max) model: change from baseline = E 0 + (E max \* dose\^Hill) / (ED 50\^Hill + dose\^Hill), where E0 is the placebo effect, E max is the maximum effect, ED 50 is the dose producing 50% of the maximum effect, and Hill is the slope parameter. Model utilized a Bayesian methodology with a robustified, informative meta-analytic predictive prior for the placebo change from baseline at week 12.

Trial Information

NCT ID

NCT05546476

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Pfizer

Last Updated

December 15, 2025

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Melanotan-I Melanotan-2