Efficacy Study of Betahistine on Body Weight in Obese Female Subjects

NCT00748436 | Completed Phase 2 DMC

• 4 other identifiers: BET2072008-001840-38S51130ML5059
• Study Type: interventional
• Target: 187
• Locations: 3 countries
• Sites: 12

Brief Summary

The purpose of this study is to examine the effect of betahistine on body weight in obese female subjects

Conditions

Obesity

Keywords

Obese females; Weight loss; Betahistine

Outcome Measures

Primary Outcomes (1)

• change in body weight in Kg or % of initial body weight and/or proportion of subjects achieving > 2.5% and/or >5.0 % weight loss.

  From baseline to week 12

Secondary Outcomes (2)

• Change in obesity associated conditions

  from baseline to Week 12

• Safety parameters

  From baseline to week 12

Study Arms (3)

A

PLACEBO COMPARATOR

Matching placebo twice a day

Drug: placebo

B

EXPERIMENTAL

Betahistine 24 mg twice a day (48 mg/day total)

Drug: betahistine dihydrochloride

C

EXPERIMENTAL

Betahistine 48 mg twice a day (96 mg/day total)

Drug: betahistine dihydrochloride

Interventions

betahistine dihydrochloride DRUG

(24mg tablet Betahistine + placebo tablet) BID per os 12 weeks

Also known as: Betahistine

B

placebo DRUG

(placebo tablet + placebo tablet) BID per os 12 weeks

A

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed written informed consent
• Female subjects 18 to 50 years of age
• Pre-menopause
• Obese with a BMI between 30 kg/m2 and 40 kg/m2
• Has been obese for at least one year prior to screening
• Non-lactating
• Non-pregnant; has a negative urine pregnancy test result, does not plan on becoming pregnant during the study be willing to continue to practice appropriate birth control (such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire study duration.

You may not qualify if:

• Has obesity of known endocrine origin (e.g., Cushing's disease, Addison's disease, hypothalamic tumor);
• Has a medical history (e.g., morbid childhood obesity) and/or physical characteristics (e.g., polydactyly) suggestive of genetic obesity (e.g., ob/ob genotype) or syndromatic obesity (e.g., Prader-Willi syndrome, Bardet Biedl syndrome);
• Previous surgical procedures for weight loss;
• Has had liposuction within 1 year before screening or is planning to have liposuction during the study;
• History of bulimia or evidence of laxative abuse;
• Has had a body weight loss of more than 4 kg in the 90 days prior to screening;
• Has taken drugs capable of influencing body weight 30 days prior to screening;
• Has recently (\<6 months prior screening) started or plans on starting a smoking cessation program;
• Has had a major change in daily physical activity (e.g., initiation of an exercise program) or started a weight loss program within 90 days prior to screening;
• Has a clinically significant history or presence of any of the following conditions:
• Active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
• Type 1 diabetes mellitus;
• Type 2 diabetes mellitus on treatment other than metformin monotherapy and/or diet with HbA1c \>8%;
• Severe type 2 diabetes with history of ketoacidosis or diabetic ulcers, or presence of retinopathy, neuropathy, or nephropathy;
• Renal insufficiency defined as a serum creatinine equal or higher than 1.5 mg/dL (133 µmol/L) at screening;

Sponsors & Collaborators

• OBEcure Ltd.: lead
• International Antiviral Therapy Evaluation Center: collaborator

Study Sites (12)

GP: Dr. Van Mulders

Aalst, 9310, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Zentrum für Therapiestudien

Leipzig, 04103, Germany

Location

CRS Clinical Research Services

Mönchengladbach, 41061, Germany

Location

Emotional Brain

Almere Stad, 1311, Netherlands

Location

GP: Dr. Rol

Bennebroek, 2121, Netherlands

Location

Wecor

Etten-Leur, 4873, Netherlands

Location

PT&R

Geleen, 6166, Netherlands

Location

AMWO

Rotterdam, 3081, Netherlands

Location

AMWO

The Hague, 2582, Netherlands

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Betahistine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yaffa Beck, PhD, CEO

  OBEcure Ltd.

  STUDY DIRECTOR

• Luc Van Gaal, MD Professor

  UZ Antwerpen

  PRINCIPAL INVESTIGATOR

• Nir Barak, MD

  OBEcure Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: September 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 7, 2009

Record last verified: 2009-05

Locations

BE (4); DE (2); NL (6)