A Phase 3 interventional study of anamorelin HCl and Placebo Oral Tablet in Cachexia; Cancer and Non Small Cell Lung Cancer, sponsored by Helsinn Healthcare SA. Completed at 65 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Helsinn Healthcare SA · Phase 3, Interventional, and Treatment
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.
The study was a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of anamorelin HCl. It was planned that approximately 316 patients with advanced NSCLC with cachexia were to be randomized 1:1 to anamorelin HCl 100 mg or placebo (158 patients per treatment group). The study treatment was to be taken orally once daily for a total of 24 weeks. Patients were instructed to take the study drug at least 1 hour before their first meal of the day.
Central randomization was stratified by line of systemic anti-cancer treatment (first line vs second line vs third line or higher), by type of anti-cancer therapy (immunotherapy vs non-immunotherapy), and by baseline score of 5 IASS (≤10 vs >10). Patients who had never received anti-cancer treatment prior to entering the study but who met all eligibility criteria were eligible to enter the study and were assigned to receive first line treatment in the Interactive Web Response System (IWRS).
Patients were to visit the site every 3 weeks for the study Treatment Period of 24 weeks. A follow-up telephone visit was to be scheduled at Week 26. Thus, patients were enrolled in the study for a maximum duration of 27 weeks (including a 1-week Screening Period, a 24-week Treatment Period, and a 2-week Follow-up Period). Each patient was scheduled to have a total of 10 planned visits plus 1 telephone contact for the Follow-up Visit.
331 studies on the registry are indexed under Cachexia; 75 are open to participants now.
This study's enrollment of 318 is above the median of 74 across 226 interventional studies indexed under Cachexia.
Browse Cachexia studies →Helsinn Healthcare SA is the lead sponsor of 32 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient receiving or not receiving systemic anti-cancer treatment at the time of screening are eligible to participate. Systemic anti-cancer treatment includes first, second, third treatment line with chemotherapy/radiation therapy, immunotherapy or targeted therapy.
Patient not receiving systemic anti-cancer treatment is eligible if:
Female patient shall be: a) of non- or b) of childbearing potential using reliable measures and having a negative urine pregnancy test within 24 hours prior to first dose of product.
Notes:
Exclusion Criteria:
Reversible causes of reduced food intake, as determined by the Investigator. These causes may include but are not limited to:
Patient with uncontrolled or significant cardiovascular disease, including:
Patient with cachexia caused by other reasons, as determined by the investigator such as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks
Drug: anamorelin HCl
Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks
Drug: Placebo Oral Tablet
100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)
Placebo (administered as matching placebo tablets in the fasted condition)
Mean Change From Baseline in Body Weight Over 12 Weeks
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.
Time frame: Mean change from baseline over 12 weeks.
Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks
This co-primary efficacy endpoint was mean change from baseline in 5-IASS (points) 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. FAACT-A/CS (Functional Assessment Anorexia Cachexia Therapy) is a 12-item measure of patients' perceptions of anorexia/cachexia symptoms and concerns. From this questionnaire, the 5-item section referring to anorexia symptoms (i.e., "good appetite," "interest in food drops," "food tastes unpleasant," "get full quickly," and "difficulty eating rich/heavy foods") was used to assess 5-IASS. The range of possible scores is 0-20. Higher scores indicate lower levels of symptom burden.
Time frame: Mean change from baseline over 12 weeks.
Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg)
The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥0 kg.
Time frame: Duration of treatment benefit from baseline over 12 weeks.
Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥1.5 kg)
The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥1.5 kg.
Time frame: Duration of treatment benefit from baseline over 12 weeks.
Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥0 Points)
The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5- IASS of ≥0 points.
Time frame: Duration of treatment benefit from baseline over 12 weeks.
Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥3 Points)
The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5- IASS of ≥3 points.
Time frame: Duration of treatment benefit from baseline over 12 weeks.
Patients were enrolled at a total of 49 study sites in Australia (2 sites), Belgium (2 sites), Croatia (3 sites), Germany (3 sites), Poland (5 sites), Romania (7 sites), Russia (10 sites), Ukraine (8 sites), and USA (9 sites). First Patient Enrollment (date of randomization) was on 06MAY2019.
| Milestone | 100 mg Anamorelin HCl | Placebo |
|---|---|---|
| Started | 154 | 164 |
| Treated | 154 | 164 |
| Completed | 83 | 90 |
| Not completed | 71 | 74 |
| Withdrew: Adverse event | 7 | 9 |
| Withdrew: Death | 25 | 28 |
| Withdrew: Lost to follow-up | 3 | 6 |
| Withdrew: Withdrawal by subject | 28 | 25 |
| Withdrew: Physician decision | 2 | 4 |
| Withdrew: Reported as "other" in clinical study report | 6 | 2 |
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.
| kg | 100 mg Anamorelin HCl | Placebo |
|---|---|---|
| Mean Change From Baseline in Body Weight Over 12 Weeks | 1.822 ± 0.263 | 0.538 ± 0.250 |
This co-primary efficacy endpoint was mean change from baseline in 5-IASS (points) 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. FAACT-A/CS (Functional Assessment Anorexia Cachexia Therapy) is a 12-item measure of patients' perceptions of anorexia/cachexia symptoms and concerns. From this questionnaire, the 5-item section referring to anorexia symptoms (i.e., "good appetite," "interest in food drops," "food tastes unpleasant," "get full quickly," and "difficulty eating rich/heavy foods") was used to assess 5-IASS. The range of possible scores is 0-20. Higher scores indicate lower levels of symptom burden.
| score on a scale | 100 mg Anamorelin HCl | Placebo |
|---|---|---|
| Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks | 3.432 ± 0.360 | 3.291 ± 0.342 |
The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥0 kg.
| weeks | 100 mg Anamorelin HCl | Placebo |
|---|---|---|
| Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg) | 8.859 ± 0.525 | 6.778 ± 0.496 |
The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥1.5 kg.
| weeks | 100 mg Anamorelin HCl | Placebo |
|---|---|---|
| Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥1.5 kg) | 5.490 ± 0.431 | 3.087 ± 0.409 |
The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5- IASS of ≥0 points.
| weeks | 100 mg Anamorelin HCl | Placebo |
|---|---|---|
| Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥0 Points) | 9.470 ± 0.392 | 8.842 ± 0.370 |
The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5- IASS of ≥3 points.
| weeks | 100 mg Anamorelin HCl | Placebo |
|---|---|---|
| Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥3 Points) | 5.143 ± 0.410 | 4.992 ± 0.387 |
Collected over Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 100 mg Anamorelin HCl | 25/154 (16.2%) | 44/154 (28.6%) | 114/154 (74%) |
| Placebo | 28/164 (17.1%) | 46/164 (28%) | 127/164 (77.4%) |
| Event | 100 mg Anamorelin HCl | Placebo |
|---|---|---|
| Non-small cell lung cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 18/154 | 19/164 |
| AnaemiaBlood and lymphatic system disorders | 4/154 | 3/164 |
| Corona virus infectionInfections and infestations | 3/154 | 2/164 |
| PneumoniaInfections and infestations | 3/154 | 3/164 |
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/154 | 1/164 |
| Cardiac disorderCardiac disorders | 2/154 | 0/164 |
| Pulmonary haemorrhageRespiratory, thoracic and mediastinal disorders | 0/154 | 2/164 |
| NeutropeniaBlood and lymphatic system disorders | 0/154 | 2/164 |
| Cancer painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/154 | 0/164 |
| Metastases to boneNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/154 | 0/164 |
| Event | 100 mg Anamorelin HCl | Placebo |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 28/154 | 38/164 |
| AstheniaGeneral disorders | 19/154 | 22/164 |
| NauseaGastrointestinal disorders | 18/154 | 12/164 |
| Non-Small Cell Lung CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 10/154 | 19/164 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 14/154 | 10/164 |
| Chest PainGeneral disorders | 13/154 | 9/164 |
| Sinus TachycardiaCardiac disorders | 7/154 | 13/164 |
| DizzinessNervous system disorders | 12/154 | 5/164 |
| DiarrhoeaGastrointestinal disorders | 10/154 | 6/164 |
| NeutropeniaBlood and lymphatic system disorders | 10/154 | 6/164 |
The Intent-to-Treat (ITT) Set included all randomized patients and was analyzed as per planned treatment.
| Age, Continuous(Years) | 100 mg Anamorelin HCl | Placebo | Total |
|---|---|---|---|
| Mean | 64.0 ± 8.49 | 63.6 ± 9.73 | 63.8 ± 9.14 |
| Sex: Female, Male(Participants) | 100 mg Anamorelin HCl | Placebo | Total |
|---|---|---|---|
| Female | 42 | 50 | 92 |
| Male | 112 | 114 | 226 |
| Ethnicity (NIH/OMB)(Participants) | 100 mg Anamorelin HCl | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 8 | 7 | 15 |
| Unknown or Not Reported | 146 | 156 | 302 |
| Race/Ethnicity, Customized(Participants) | 100 mg Anamorelin HCl | Placebo | Total |
|---|---|---|---|
| Asian | 4 | 4 | 8 |
| Black or African American | 0 | 2 | 2 |
| White | 148 | 157 | 305 |
| Other | 0 | 1 | 1 |
| Multiple | 2 | 0 | 2 |
| Region of Enrollment(Participants) | 100 mg Anamorelin HCl | Placebo | Total |
|---|---|---|---|
| Romania | 58 | 59 | 117 |
| Belgium | 2 | 3 | 5 |
| United States | 8 | 8 | 16 |
| Ukraine | 38 | 34 | 72 |
| Poland | 11 | 19 | 30 |
| Australia | 1 | 3 | 4 |
| Croatia | 5 | 5 | 10 |
| Russia | 27 | 29 | 56 |
| Germany | 4 | 4 | 8 |
| Height(cm) | 100 mg Anamorelin HCl | Placebo | Total |
|---|---|---|---|
| Mean | 171.03 ± 8.690 | 169.96 ± 9.164 | 170.48 ± 8.940 |
| Weight(kg) | 100 mg Anamorelin HCl | Placebo | Total |
|---|---|---|---|
| Mean | 54.09 ± 7.029 | 52.84 ± 7.925 | 53.44 ± 7.519 |
| Body Mass Index(kg/m^2) | 100 mg Anamorelin HCl | Placebo | Total |
|---|---|---|---|
| Mean | 18.38 ± 1.328 | 18.16 ± 1.579 | 18.27 ± 1.465 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Anamorelin