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Completed Phase 3 Interventional Results available

A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) - 1

ClinicalTrials.gov ID: NCT03743051

Public ClinicalTrials.gov record NCT03743051. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 10:15 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this clinical trial was to compare the efficacy and safety of anamorelin HCl (the investigational drug) to that of placebo (tablet with no drug) in patients with advanced non-small cell lung cancer and cachexia (cancer-related weight loss). The main question it aimed to answer was as follows: Do patients who receive anamorelin HCl gain more body weight and show more improvement in anorexia symptoms than those who receive placebo. Approximately 316 patients were to be enrolled in the study. Of these patients, an equal number were to be assigned to each treatment group (anamorelin HCl or placebo). Participants were to take their assigned study drug by mouth once daily for a total of 24 weeks. During this treatment period, the patients were to visit the clinical study site every 3 weeks for health and other study-related assessments. Two weeks after the last treatment, patients were to receive a follow-up phone call.

Study identification

NCT ID
NCT03743051
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Helsinn Healthcare SA
Industry
Enrollment
318 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 5, 2019 (Actual)
Primary completion
Feb 11, 2023 (Actual)
Completion
Feb 11, 2023 (Actual)
Last update posted
Oct 6, 2026

2019 – 2023

United States locations

U.S. sites
24
U.S. states
17
U.S. cities
24
Facility City State ZIP Site status
Chen Tucson Arizona 85745 —
CARTI Cancer Center Little Rock Arkansas 72205 —
The Oncology Insitute of Hope and Innovation Riverside California 92506 —
Hartford HealthCare Cancer Institute at the Hospital of Central Connecticut Plainville Connecticut 06062 —
21st Century Oncology Jacksonville Florida 32204 —
Mid Florida Hematology and Oncology Center Orange City Florida 32763 —
Rush University Medical Center Chicago Illinois 60612 —
Joliet Oncology Hematology Associates, Ltd Joliet Illinois 60435 —
Goshen Center for Cancer Care Goshen Indiana 46526 —
McFarland Clinic, PC Ames Iowa 50010 —
MercyOne Waterloo Cancer Center Waterloo Iowa 50702 —
Jackson Oncology Associates, PLC Jackson Minnesota 39216 —
Trinitas Comprehensive Cancer Center/Trinitas Regional Medical Center Elizabeth New Jersey 07207 —
Englewood Health Englewood New Jersey 07631 —
Broome Oncology LLC Johnson City New York 13790 —
Northwell Health Lake Success New York 11042 —
Stony Brook Cancer Center Stony Brook New York 11794 —
Ohio State University Wexner Medical Center The James Cancer Hospital and Solove Research Institute Columbus Ohio 43210 —
Gettysburg Cancer Center Gettysburg Pennsylvania 17325 —
Tennessee Cancer Specialist Knoxville Tennessee 37909 —
Community Cancer Trial of Utah Ogden Utah 84405 —
Virginia Commonwealth University, Massey Cancer Center Richmond Virginia 23298-0230 —
Kadlec Clinic Hematology and Oncology Kennewick Washington 99336 —
Wenatchee Valley Hospital & Clinics Wenatchee Washington 98801 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 48 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03743051, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 6, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03743051 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →