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Ghrelin Receptor Agonist

Anamorelin Hydrochloride for Cancer Cachexia

Phase 3
Waitlist Available
Research Sponsored by Helsinn Healthcare SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until week 12
Awards & highlights

Study Summary

This trial is testing if a new drug, anamorelin HCl, is better than placebo at treating cachexia in patients with advanced lung cancer. The trial will last 24 weeks.

Eligible Conditions
  • Cancer Cachexia
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
5 item Anorexia Symptom Subscale
FAACT 12-item A/CS domain
FAACT total score
+2 more
Other outcome measures
Composite Clinical Response (CCR)

Side effects data

From 2023 Phase 1 trial • 32 Patients • NCT04021706
12%
GI bloating
6%
hematuria
6%
high blood sugar
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anamorelin
Microcrystaline Cellulose

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 100mg Anamorelin HClExperimental Treatment1 Intervention
Group II: placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anamorelin Hydrochloride
2019
Completed Phase 3
~350

Find a Location

Who is running the clinical trial?

Helsinn Healthcare SALead Sponsor
41 Previous Clinical Trials
9,143 Total Patients Enrolled
1 Trials studying Cancer Cachexia
318 Patients Enrolled for Cancer Cachexia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the benefits that patients can hope to receive from this clinical trial?

"The purpose of this 12-week clinical trial is to evaluate the efficacy of the medication in question by measuring the duration of clinically meaningful treatment benefit in patients with anorexia nervosa. Secondary objectives include determining the mean change in FAACT 12-item A/CS domain, as well as measuring duration of treatment benefits for weight and Anorexia Symptom Subscale (≥ to a predefined threshold)."

Answered by AI

How many people are currently signed up for this clinical trial?

"This study is not currently looking for patients. It was first posted on December 18th, 2018 and updated September 5th, 2022. There are 2416 other trials related to non-small cell lung carcinoma (NSCLC) that are actively recruiting participants and 6 for Anamorelin Hydrochloride."

Answered by AI

Can you give some examples of other research done on Anamorelin Hydrochloride?

"The first study involving Anamorelin Hydrochloride was completed in 2017 at M D Anderson Cancer Center. 175 studies have been concluded thus far, with 6 more clinical trials underway. The majority of these new tests are taking place in Kennewick, Washington."

Answered by AI

What are the possible dangers associated with Anamorelin Hydrochloride?

"Since this is a Phase 3 trial, there is already some data to support efficacy and multiple rounds of safety data. Therefore, the Power team has given Anamorelin Hydrochloride a score of 3 for safety."

Answered by AI

Are researchers looking for new participants in this trial?

"No, this particular trial is not enrolling patients right now. The study was originally posted on December 18th 2018 but the most recent update was on September 5th 2022. There are 2422 other trials that are actively looking for participants."

Answered by AI

In how many different places is this research project being conducted?

"This trial is currently recruiting patients from 24 different locations, including Kadlec Clinic Hematology and Oncology in Kennewick, Goshen Center for Cancer Care in Goshen, Rush University Medical Center in Chicago, amongst other sites."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
65+
What site did they apply to?
trinitas comprehensive cancer center/Trinitas Regional Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~50 spots leftby Apr 2025