A Proof of Concept Trial in Overweight and Obese Patients, Investigating Effect of EMP16-02 on Body Weight (Primary)

NCT04521751 | Completed Phase 1

• 1 other identifier: EP-002
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a proof of concept study to demonstrate that EMP16-02, a fixed dose combination (FDC) of orlistat and acarbose in an oral multiple-unit modified release (MR) formulation leads to a clinically relevant decrease in body weight. The study aims to evaluate the efficacy, safety and tolerability of treatment with two different doses of EMP16 02 (120 mg orlistat/40 mg acarbose and 150 mg orlistat/50 mg acarbose) for 26 weeks on reducing body weight in obese patients.

Conditions

Overweight or Obesity

Keywords

Overweight; Obesity; Orlistat; Acarbose

Outcome Measures

Primary Outcomes (1)

• Body weight, relative (%) change from baseline for EMP16-02 (120 mg O/40 mg A)

  Relative (%) change from baseline in body weight after 26 weeks of treatment with EMP16-02 (120 mg O/40 mg A) as compared to placebo.

  From first dose to last dose (week 26). Measured at baseline and week 26.

Secondary Outcomes (58)

• Body weight, absolute change from baseline for EMP16-02 (120 mg O/40 mg A)

  From first dose to last dose (week 26). Measured at baseline, week 14 and week 26.

• Body weight, relative (%) and absolute change from baseline for EMP16-02 (150 mg O/50 mg A)

  From first dose to last dose (week 26). Measured at baseline, week 14 and week 26.

• Proportion of patients with ≥5% and ≥10% decrease in body weight for EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A)

  From first dose to last dose (week 26). Measured at baseline, week 14 and week 26.

• BMI, relative (%) and absolute change from baseline for EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A)

  From first dose to last dose (week 26). Measured at baseline, week 14 and week 26.

• Waist circumference, absolute change from baseline for EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A)

  From first dose to last dose (week 26). Measured at baseline, week 14 and week 26.

Study Arms (3)

EMP16-02 120 mg orlistat/40 mg acarbose

EXPERIMENTAL

Dosage form: Oral, modified-release (MR) fixed dose combination (FDC) of orlistat and acarbose formulated in capsules. Dosage: 120 mg O/40 mg A (given as 2 capsules EMP16-02-60/20). Frequency: Three times daily (TID) together with the three main daily meals .Taken halfway through each meal, together with approximately 100-200 mL water (or other drink). Duration: 26 weeks.

Drug: EMP16-02 120 mg orlistat/40 mg acarbose

EMP16-02 150 mg orlistat/50 mg acarbose

EXPERIMENTAL

Dosage form: Oral, modified-release (MR) fixed dose combination (FDC) of orlistat and acarbose formulated in capsules. Dosage: 150 mg O/50 mg A (given as 1 capsule EMP16-02-90/30 and 1 capsule EMP16-02-60/20). Frequency: Three times daily (TID) together with the three main daily meals .Taken halfway through each meal, together with approximately 100-200 mL water (or other drink). Duration: 26 weeks.

Drug: EMP16-02 150 mg orlistat/50 mg acarbose

Placebo

PLACEBO COMPARATOR

Dosage form: Matching, oral capsule. Identical in appearance but contain only cellulose. Dosage: Placebo (given as 2 placebo capsules) Frequency: Three times daily (TID) together with the three main daily meals .Taken halfway through each meal, together with approximately 100-200 mL water (or other drink). Duration: 26 weeks.

Drug: Placebo

Interventions

EMP16-02 120 mg orlistat/40 mg acarbose DRUG

EMP16-02 capsules are composed of three pharmaceutical fractions (granules denoted G1, G2 and G3). G1= Prolonged release of acarbose, G2= Enteric-coated granule fraction containing orlistat and acarbose, G3= Orlistat with a delayed on-set release mechanism.

Also known as: 120 mg O/40 mg A

EMP16-02 120 mg orlistat/40 mg acarbose

EMP16-02 150 mg orlistat/50 mg acarbose DRUG

EMP16-02 capsules are composed of three pharmaceutical fractions (granules denoted G1, G2 and G3). G1= Prolonged release of acarbose, G2= Enteric-coated granule fraction containing orlistat and acarbose, G3= Orlistat with a delayed on-set release mechanism.

Also known as: 150 mg O/50 mg A

EMP16-02 150 mg orlistat/50 mg acarbose

Placebo DRUG

Matching oral placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give written informed consent for participation in the study.
• Aged ≥ 18 and ≤ 75 years.
• BMI ≥ 30 or ≥ 28 kg/m² in the presence of other risk factors based on patient interview, e.g., hypertension (either or not treated with antihypertensive agents), glucose dysregulation such as impaired glucose tolerance (defined as elevated fasting glucose or HbA1c as judged by the Investigator) and T2DM that is treated with life style changes (no medication allowed), and/or dyslipidaemia (either or not treated with antihyperlipidemic agents). If indicated, plasma/serum total cholesterol, LDL, HDL, and triglycerides can be measured to verify eligibility as judged by the Investigator.
• Acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
• Adequate renal and hepatic function as judged by the Investigator in accordance with the expected disease profile
• Weight stable (\<5% reported change during the three months preceding screening), based on patient interview and weight assessments at screening (Visit 1) and randomisation (Visit 2).
• Willing to eat three meals per day, and willing to eat breakfast during the visits to the clinic.
• Males and females may be included in the study. WOCBP must agree to use a highly effective method of contraception with a failure rate of \< 1% to prevent pregnancy (combined \[oestrogen and progestogen containing\] hormonal contraception associated with inhibition of ovulation \[oral, intravaginal, transdermal\], progestogen-only hormonal contraception associated with inhibition of ovulation \[oral, injectable, implantable\], intrauterine device \[IUD\]or intrauterine hormone-releasing system \[IUS\]) OR practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the patient) from at least 4 weeks prior to first dose to 4 weeks after last dose.
• Women of non-childbearing potential are defined as pre-menopausal females who are sterilised (tubal ligation or permanent bilateral occlusion of fallopian tubes); or post menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with simultaneous detection of follicle stimulating hormone \[FSH\] 25 140 IE/L).

You may not qualify if:

• T2DM treated with medication.
• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks prior to the first administration of IMP, at the discretion of the Investigator.
• Any planned major surgery within the duration of the study.
• Untreated high blood pressure (above 160/100 mmHg at screening).
• Use of any of the prohibited medication listed in Table 9.6 1 within 2 weeks prior to the first administration of IMP. Recently started use of anti-depressants (e.g., selective serotonin re-uptake inhibitors \[SSRI\]) within 2 weeks prior to the first IMP administration or planned start of anti-depressant treatment during the study period is not allowed, yet patients that are on stable treatment with anti-depressants for at least two months can be included.
• Known hypersensitivity to any of the test substances. History of hypersensitivity to drugs with a similar chemical structure or class to orlistat and acarbose.
• Gastrointestinal problems/diseases, e.g., inflammatory bowel diseases and Irritable Bowel Syndrome (IBS). Untreated gastroesophageal reflux disease (GERD) or GERD that is treated occasionally is allowed as judged by the Investigator.
• Cholestasis.
• Previous gastrointestinal surgery that might influence gastrointestinal function significantly, previous bariatric surgery, and previous gallbladder surgery as judged by the investigator.
• Known vitamin B12 deficiency or other signs of achlorhydria.
• Chronical malabsorption syndrome.
• Clinically significant abnormal laboratory values at screening as judged by the investigator.
• History of severe allergic, cardiac or hepatic disease. History of significant cardiovascular disease such as myocardial infarction, congestive heart failure, stroke, serious cardiac arrhythmias. History of angina within 6 months prior to screening.
• A personal or family history of Medullary Thyroid Carcinoma (MTC).

Sponsors & Collaborators

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

Study Sites (2)

Clinical Trial Consultants AB

Linköping, 58758, Sweden

Location

Clinical Trial Consultants AB

Uppsala, 75237, Sweden

Location

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

• Helena Litorp, MD, PhD

  CTC Clinical Trial Consultants AB

  PRINCIPAL INVESTIGATOR

• Daniel Wilhelms, MD, PhD

  CTC Clinical Trial Consultants AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study and the allocation of treatments will not be disclosed until clean file has been declared and the database has been locked. Active treatment and placebo capsules are identical in appearance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an exploratory, randomised, double-blind and placebo-controlled study.

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: August 21, 2020
• Study Start: May 7, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: April 4, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)