An interventional study of Zenpep and Placebo in Malnutrition, sponsored by Philipp Schuetz. Recruiting at 1 site in Switzerland. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Philipp Schuetz · Not applicable, Interventional, and Treatment
This study investigates if pancreatic enzymes in combination with oral nutritional supplement can improve nutrient bioavailability in older people with malnutrition or at risk of malnutrition.
This study investigates whether adding digestive pancreatic enzymes to oral nutritional supplements (ONS) can improve nutrient absorption in older adults at risk of malnutrition. While ONS are commonly recommended, their effectiveness is often limited due to age-related declines in exocrine pancreatic function, leading to reduced enzyme secretion. Studies indicate that pancreatic lipase levels decline with age, potentially impairing nutrient digestion and absorption.
The study proposes using pancrelipase (Zenpep®), an FDA-approved pancreatic enzyme replacement therapy, to enhance nutrient bioavailability. The randomized, placebo-controlled trial will assess whether pancrelipase improves postprandial levels of amino acids, fatty acids, and glucose in hospitalized patients at nutritional risk.
The study aims to determine if pancreatic enzyme supplementation can enhance nutrient absorption and provide a novel strategy for managing malnutrition in older adults without diagnosed exocrine pancreatic insufficiency (EPI). If successful, this approach could improve clinical outcomes, reduce healthcare costs, and enhance quality of life.
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's planned enrollment of 20 is below the median of 118 across 843 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Philipp Schuetz is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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.
Exclusion Criteria:
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
two capsules each containing 15000 USP units of lipase
Drug: Zenpep
two capsules each containing placebo
Drug: Placebo
two capsules (each containing 15000 USP units of lipase) together with nutritional supplements
Also known as: Pancrelipase
two capsules (containing placebo) together with nutritional supplements
Also known as: lactose monohydrate
Incremental area under the curve of total branched-chained amino acid concentration
Evaluation of the incremental area under the curve (iAUC) of total branched-chain amino acid (BCAA) concentration in blood, including leucine (μmol/L), isoleucine (μmol/L), and valine (μmol/L). The iAUC represents the time-dependent changes in BCAA levels and is used to assess metabolic responses.
Time frame: From oral nutritional supplements (ONS) consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)
Incremental area under the curve of essential amino acids (EAAs)
Evaluation of the incremental area under the curve (iAUC) of essential amino acids (EAAs) in plasma, expressed in micromoles per liter (μmol/L). The iAUC reflects the time-dependent changes in EAAs concentrations and is used to assess metabolic responses.
Time frame: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)
Incremental area under the curve of total amino acids
Evaluation of the incremental area under the curve (iAUC) of total amino acids in plasma, expressed in micromoles per liter (μmol/L). The iAUC reflects the time-dependent changes in total amino acid concentrations and is used to assess metabolic responses.
Time frame: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)
Incremental area under the curve of free fatty acids
Evaluation of the incremental area under the curve (iAUC) of free fatty acids in plasma, expressed in micromoles per liter (μmol/L). The iAUC reflects the time-dependent changes in free fatty acid concentrations and is used to assess metabolic responses.
Time frame: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)
Incremental area under the curve of triglycerides
Evaluation of the incremental area under the curve (iAUC) of triglycerides in plasma, expressed in millimoles per liter (mmol/L). The iAUC reflects the time-dependent changes in triglycerides concentrations and is used to assess metabolic responses.
Time frame: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)
Water load satiety test (WLST)
Values of a modified water load satiety test (WLST), a questionnaire of 5 sub-scores on a scale of 1-100. We will report both the sum of the scores and the 5 individual sub scales will be reported. Participant rate pre-and postprandial intensity of symptoms for fullness, hunger, abdominal discomfort, bloating, and nausea on a 0-100 mm visual analogue scale where 0 is none, and 100 is severe
Time frame: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)
Exploratory subgroup analysis
Exploratory subgroup analyses to test their effect on the primary outcome (incremental area under the curve (AUC) of total branched-chained amino acid concentration in the blood) will be performed. These will be assessed using a t-test on the differences between pancrelipase and placebo for each patient. Groups are based on the subgroup including median age \[years\], malnutrition risk \[Nutritional Risk Screening 2002 total score\], median weight \[kg\], sex \[male/female\], prior history of gastrointestinal side effects \[yes/no\], median fecal elastase \[μg/g\]
Time frame: After study completion, within 1 year
Incremental area under the curve of glucose
Evaluation of the incremental area under the curve (iAUC) of glucose in plasma, expressed in millimoles per liter (mmol/L). The iAUC reflects the time-dependent changes in glucose concentrations and is used to assess metabolic responses.
Time frame: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)
Started Sep 2025 (actual). Primary completion is estimated for Jan 2027, 16 months after the start.
Of 392 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 16 months is below that.
Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Pancrelipase