A Phase 1 Study to Evaluate EMP22 PD and EMP16 PK Versus Xenical® in Healthy Volunteers

NCT06013163 | Unknown Phase 1

• 2 other identifiers: EP-0042023-505671-74-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I, active-controlled, randomised trial will be conducted in 2 parts. Part I aims to confirm the PD equivalence of EMP22 and Xenical® based on percent fecal fat excretion at steady state. EMP22 (also referred to as MR orlistat) has the same MR properties as EMP16 but lacks the acarbose component. Part II will explore the PK properties of EMP16 alone and vs. Xenical®. Part I will be conducted in a single-blind, cross-over fashion while Part II will have an open-label, fixed-sequence design. Healthy volunteers will be recruited to the trial.

Conditions

Overweight or Obesity

Keywords

Overweight, Obesity

Outcome Measures

Primary Outcomes (1)

• The percent of faecal fat

  The percent of faecal fat excretion expressed as a ratio of the amount of fat excretion over a 24-hour period at steady-state relative to the amount of daily ingested fat.

  Day -2 , Day -1 , and between the morning of Day 9 and Day 10.

Secondary Outcomes (6)

• Cmax - to explore the PK properties of EMP16

  12 hour for each day of treatment

• Tmax - to explore the PK properties of EMP16

  12 hour for each day of treatment

• AUC0-t - to explore the PK properties of EMP16

  12 hour for each day of treatment

• Cmax - to compare the bioavailability of orlistat in EMP16 and Xenical®

  12 hour for each day of treatment

• Tmax - to compare the bioavailability of orlistat in EMP16 and Xenical®

  12 hour for each day of treatment

Study Arms (3)

Xenical - EMP22 part 1 crossover blinded

ACTIVE COMPARATOR

After a 5-day diet run-in period, orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken 3 times daily (ter in die \[TID\]) together with the 3 main daily meals for a 9-day treatment period. After a 4-to-14-day wash-out period; EMP22 (120 mg modified release orlistat) will be taken TID together with the 3 main daily meals for a 9-day treatment period.

Drug: Xenical® vs EMP 22

EMP22 - Xenical part 1 crossover blinded

ACTIVE COMPARATOR

After a 5-day diet run-in period, EMP22 (120 mg modified release orlistat) will be taken 3 times daily (ter in die \[TID\]) together with the 3 main daily meals for a 9-day treatment period. After a 4-to-14-day wash-out period; orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken TID together with the 3 main daily meals for a 9-day treatment period.

Drug: EMP 22 vs Xenical®

EMP16 - Xenical part 2 sequential open label

ACTIVE COMPARATOR

Single dose of EMP16 (120 mg orlistat/40 mg acarbose) will be taken together with breakfast during one PK study day. After a 4-to-14-day wash-out period, Xenical® (120 mg orlistat) will be taken together with breakfast during one PK study day.

Drug: EMP 16 vs Xenical®

Interventions

Xenical® vs EMP 22 DRUG

Each participant will first use Xenical® TID for 9 days and then EMP22TID for 9 days (in total 27 doses of each drug).

Also known as: Part I

Xenical - EMP22 part 1 crossover blinded

EMP 22 vs Xenical® DRUG

Each participant will first use EMP22 TID for 9 days and then Xenical® TID for 9 days (in total 27 doses of each drug).

Also known as: Part I

EMP22 - Xenical part 1 crossover blinded

EMP 16 vs Xenical® DRUG

Each participant will receive a single dose of EMP16 and then a single dose of Xenical®.

Also known as: Part II

EMP16 - Xenical part 2 sequential open label

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to give written informed consent for participation in the trial.
• Healthy male or female aged 20 to 55 years inclusive.
• Participants with a BMI between 20 and 27 kg/m² or participants with a BMI \>27 kg/m2 and normal body fat composition (10 to 25% for men and 20 to 30% for women measured using a bioimpedance scale) at screening.
• Weight stable (\<5% self-reported change during the previous 3 months preceding screening).
• Participants with a self-perceived normality in defecation habits, normally with a stool frequency of at least once daily.
• Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, electrocardiogram (ECG) and laboratory values at the time of the screening visit, as judged by the Investigator.

You may not qualify if:

• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial including but not limited to:
• GI problems/diseases, e.g. inflammatory bowel diseases and irritable bowel syndrome (IBS).
• Cholestasis.
• Previous GI surgery that might influence GI function significantly, such as previous bariatric surgery, and previous gallbladder surgery as judged by the investigator.
• Vitamin B12 deficiency or other signs of achlorhydria.
• Chronical malabsorption syndrome.
• History of severe allergic, cardiac or hepatic disease.
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
• Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
• Any planned major surgery within the duration of the trial.
• Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
• Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).
• Prolonged QTcF (\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class as orlistat or acarbose.
• Regular use of any prescribed or non-prescribed medications (including, but not limited to, antacids, analgesics, herbal remedies, vitamins and minerals) within 2 weeks prior to the first administration of IMP except as outlined in Section 9.6.2.3.

Sponsors & Collaborators

• Empros Pharma AB: lead
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (1)

CTC Clinical Trial Consultanta AB

Uppsala, 752 37, Sweden

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulf Holmbäck

  Empros Pharma

  STUDY CHAIR

Central Study Contacts

Ulf Holmbäck, PhD

CONTACT

+4670 173 00 41; ulf.holmback@emprospharma.com

Ulf Holmbäck

CONTACT

+4670 173 00 41; ulf.holmback@emprospharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Part I: EMP22 and Xenical® have different strengths of orlistat, 60 mg and 120 mg, respectively. In order to maintain the blind, the IMP will be administered as follows: * EMP22 60 mg orlistat, 2 capsules TID. * Xenical® 120 mg orlistat 1 capsule + placebo 1 capsule TID. EMP22, Xenical® and placebo will be identical in appearance. Part II will be open-label, i.e., the Investigator, trial staff and trial participants will know which treatment, EMP16 or Xenical®, that is given at each visit.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In Part I (single-blind), EMP22 (120 mg orlistat) and orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken 3 times daily (ter in die \[TID\]) together with the 3 main daily meals for two 9-day treatment periods in a cross-over manner. In Part II (open-label), single doses of EMP16 (120 mg orlistat/40 mg acarbose) and Xenical® (120 mg orlistat) will be taken together with breakfast on 2 separate days.

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: September 22, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

SE (1)