Clinical trialPhase 2Terminated

Anamorelin Study for Advanced Pancreatic Cancer

A Randomized, Double-blind, and Placebo Controlled Multicenter Phase II Trial Evaluating Anamorelin in the Prevention of Cancer Induced-Weight Loss and Anorexia in Patients Receiving First-line Treatment of Advanced Pancreatic Cancer

NCT04844970 ↗ ClinicalTrials.gov, retrieved 14 November 2026

Outcome: Stopped early. Results posted; no primary outcome with dataThe study closure was initiated by the financial sponsor and agreed upon by the site PI. The study is closing because of low enrollment and insufficient funds. (Business decision)
Phase: Phase 2
Status: Terminated
Study type: Interventional
Start: 1 April 2023
Ended: 7 November 2023
Enrollment: 4 participants
Sites: 1
Primary outcomes: Percent Weight Change From Baseline to Week 25
Sponsor type: Academic / other
Results posted: 17 November 2025
Last update: 17 November 2025

These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.

Results

Primary endpoint: Results posted; no primary outcome with dataAs posted on ClinicalTrials.gov ↗, registry record of 17 November 2025
Primary outcome, no data: Percent Weight Change From Baseline to Week 25The registry’s note: No patients were analyzed for this outcome measure because no weight was collected at the 25-week time point.
Participants: Anamorelin: 2 started, 0 completedPlacebo: 2 started, 1 completed
Serious adverse events: Anamorelin: 0 of 2Placebo: 1 of 2Participants with at least one serious adverse event, of those at risk, as posted

7 secondary outcomes, the first 3 shown

Survival: Placebo 1/1 [Participants]
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0: Anamorelin 0/2; Placebo 1/2 [Participants]
Adverse Events: Anamorelin 0, n=2; Placebo 0, n=2 [of events]

Every value is copied from the trial’s results record at ClinicalTrials.gov. “Statistically significant” describes the posted test only: it does not say which group did better, and nothing here is read from a paper.

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Brief summary public domain (ClinicalTrials.gov)

Multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of anamorelin HCl. Approximately 100 subjects with advanced PDAC and cachexia will be randomized 1:1 to anamorelin HCl 100 mg or placebo, taken orally once daily (QD) for a total of 25 weeks. Subjects will be instructed to take the study drug at least 1 hour before their first meal of the day

Detailed description public domain (ClinicalTrials.gov)

Anorexia and cachexia are common clinical sequelae of uncontrolled, metastatic cancer. These effects can impair physical function, reduce quality of life, impair tolerability of anticancer therapy, and reduce survival. Anorexia and cachexia are especially challenging problems in patients diagnosed with metastatic pancreatic cancer. With an annual incidence approaching 50,000 patients in the U.S. alone, pancreatic cancer has an annual mortality of approximately 40,000 patients with most individuals succumbing to their disease within two years. Between 70-80% of patients with metastatic pancreatic cancer experience cancer cachexia, which has been associated with reduced survival, increased risk of disease progression, and impaired chemotherapy tolerance. Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects. Several randomized, double-blind, clinical trials in cancer patients have shown that anamorelin HCL is safe, efficacious and increases lean body mass, bodyweight, and appetite. Investigators propose to test anamorelin HCL administered with chemotherapy in the first-line treatment of locally advanced unresectable and metastatic pancreatic cancer. The study is a randomized, placebo controlled multicenter, Phase II trial to evaluate the efficacy and safety of anamorelin HCl. Approximately 100 patients with be enrolled in a 1:1 randomization to anamorelin HCL 100mg per day given concurrently with first-line chemotherapy compared to chemotherapy alone. Patients randomized to anamorelin HCL will take it daily for 24 weeks starting one day prior to chemotherapy. All patients will undergo an assessment by a certified nutritionist at or prior to their first cycle of chemotherapy. Both body weight and appetite will be measured at enrollment as well as at the initiation of chemotherapy. Patients will be stratified by degree of weight loss in the six months prior to enrollment, choice of first-line chemotherapy, and by baseline score of 5-item Anorexia Symptom Scale.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Percent Weight Change From Baseline to Week 25 [25 weeks from baseline].