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NCT03743051 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Helsinn Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 318
- Enrollment target
NCT03743051: Completed Phase 3 study, sponsored by Helsinn Healthcare.
NCT03743051 is a Phase 3 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 318 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03743051, a Phase 3 study, has completed, sponsored by Helsinn Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 318 participants
- Enrollment target
Study Summary
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.
Primary Outcome
This co-primary efficacy endpoint was mean change from baseline in body weight (kg) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment.
Interventions
- DRUG Placebo Oral Tablet
- DRUG Anamorelin Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2019-03-05 |
| Est. Completion | 2023-02-11 |
| Phase | Phase 3 |
What the finished NCT03743051 record still lists
NCT03743051 is an interventional study that assigns participants to a tested intervention. The registered 318 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03743051 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03743051 about?
NCT03743051 is a clinical study titled "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)". 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 fol...
What is the current status of trial NCT03743051?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 318 participants. The study started on 2019-03-05. Estimated completion is 2023-02-11.
What interventions are being tested in trial NCT03743051?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Anamorelin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03743051?
This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03743051's enrollment target sits among peer trials
318 1087th of 2000 higher than 912 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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