The Antiemetic Effects of Increased Splanchnic Perfusion, Induced by the Gut Hormone GIP, in Healthy Individuals (GIP EMESIS)

This study investigates whether the gut hormone glucose-dependent insulinotropic polypeptide (GIP) can reduce feelings of nausea. GIP is naturally released after meals and is administered intravenously to healthy participants during the experiment. Nausea is induced using either glucagon-like peptide 1 (GLP-1), another gut hormone, or apomorphine, a medication known to trigger nausea. By combining these substances, the study aims to determine whether GIP can alleviate nausea. The findings may improve understanding of interactions between the gut and the brain.

Study Overview

• Status: Enrolling by invitation
• Conditions: Emesis
• Intervention / Treatment: Other: GLP-1 (7-36) amide; Other: Saline (0.9% NaCl); Other: Glucose-dependent Insulinotropic Polypeptide (GIP); Other: Apomorphine Injectable Solution

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Center for Clinical Metabolic Research, Herlev-Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men or women, age of 18-60 years
• BMI between 19-27 kg/m2 (both included)
• informed consent

Exclusion Criteria:

• Current or past treatment with GLP-1 or GIP/GLP-1 receptor-targeting compounds within the last six months
• Gastrointestinal disorders that the investigator evaluates could interfere with induction of nausea (e.g. gastroparesis, functional dyspepsia and GI surgery)
• Neurological disorders affecting nausea (e.g. severe migraines and neuropathy)
• Any known eating disorders (e.g. anorexia nervosa and bulimia)
• Pregnancy or breastfeeding
• Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (> 2 times normal values) or present hepatobiliary disease
• Kidney disease (estimated glomerular filtration rate (eGFR)<90 ml/min/1.73 m2) at screening
• Severe arteriosclerotic heart disease or heart failure (NYHA class II-IV)
• Glycated hemoglobin (HbA1c) ³ 48 mmol/mol and/or diagnosed type 1 or type 2 diabetes
• Any condition that the investigator evaluates would interfere with study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: s.c. injection of GLP-1 and infusion of saline	Other: GLP-1 (7-36) amide; gut hormone - GLP-1(7-36)NH2; Other: Saline (0.9% NaCl); Placebo
Active Comparator: s.c. injection of GLP-1 and infusion of GIP	Other: GLP-1 (7-36) amide; gut hormone - GLP-1(7-36)NH2; Other: Glucose-dependent Insulinotropic Polypeptide (GIP); GIP - gut hormone
Active Comparator: s.c. injection of apomorphine and infusion of saline	Other: Saline (0.9% NaCl); Placebo; Other: Apomorphine Injectable Solution; used as a tool to induce nausea
Active Comparator: s.c. injection of apormorphine and infusion of GIP	Other: Glucose-dependent Insulinotropic Polypeptide (GIP); GIP - gut hormone; Other: Apomorphine Injectable Solution; used as a tool to induce nausea
Placebo Comparator: s.c. injection of saline and infusion of GIP	Other: Saline (0.9% NaCl); Placebo; Other: Glucose-dependent Insulinotropic Polypeptide (GIP); GIP - gut hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in GLP-1 induced nausea intensity	The primary endpoint is the change in GLP-1-induced nausea intensity, measured by a 0-100 mm visual analogue scale (VAS), between study visits, with and without GIP infusion.	From enrollment to the end of treatment at up to 12 weeks.

Collaborators and Investigators

• Sponsor: University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): April 28, 2027

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: GLP-1; nausea; emesis; GIP; incretin hormones
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nausea; Vomiting; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pharmacologic Actions; Chemical Actions and Uses; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Incretins; Sodium Chloride; glucagon-like peptide 1 (7-36)amide
• Other Study ID Numbers: H-25050058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No