A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Betahistine on Body Weight in Obese Female Subjects - BET207

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001840-38-BE

Enrollment

180

Registered

2008-06-16

Start date

2008-08-05

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesity MedDRA version: 9.1 Level: LLT Classification code 10029883 Term: Obesity

Interventions

Trade Name: Microser Product Name: betahistine Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed written informed consent; - Female subjects 18 to 50 years of age; - Pre-menopause; - Obese with a BMI > or = 30 kg/m2 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Has obesity of known endocrine origin (e.g., Cushing’s disease, Addison’s disease, hypothalamic tumor), genetic obesity or syndromatic obesity (e.g., Prader-Willi syndrome, Bardet Biedl syndrome); - Previous surgical procedures for weight loss; - History of bulimia or evidence of laxative abuse; - Active or past history of cardiovascular or cerebrovascular disease - Type 1 diabetes mellitus; - Type 2 diabetes mellitus on treatment other than metformin monotherapy and/or diet with HbA1c >8%; - Renal insufficiency defined as a serum creatinine > or = 1.5 mg/dL (133 µmol/L) at screening; - History of asthma, peptic ulcers or HIV; - Chronic use of antihistamines;

Design outcomes

Primary

Measure	Time frame
Main Objective: • To examine the effect of betahistine on body weight in obese female subjects ;Secondary Objective: • To investigate the effect of betahistine in obese female subjects on the following: - Waist circumference; - Other obesity-related risk factors (blood pressure, plasma lipids, hemoglobin A1c [HbA1c], and fasting plasma glucose [FPG]); - Alertness - Sexual behavior. - Appetite and satiety - Safety and tolerability of betahistine • To investigate pharmacokinetic parameters of betahistine in obese female subjects ;Primary end point(s): Change in body weight (in kg and/or % of body weight) from baseline (randomisation) to week 12 achieving > 2.5% and/or > 5% weight loss between baseline and visit 12.	—

Measure

Time frame

Main Objective: • To examine the effect of betahistine on body weight in obese female subjects ;Secondary Objective: • To investigate the effect of betahistine in obese female subjects on the following: - Waist circumference; - Other obesity-related risk factors (blood pressure, plasma lipids, hemoglobin A1c [HbA1c], and fasting plasma glucose [FPG]); - Alertness - Sexual behavior. - Appetite and satiety - Safety and tolerability of betahistine • To investigate pharmacokinetic parameters of betahistine in obese female subjects ;Primary end point(s): Change in body weight (in kg and/or % of body weight) from baseline (randomisation) to week 12 achieving > 2.5% and/or > 5% weight loss between baseline and visit 12.

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Countries

Belgium, Germany, Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026