NCT01272739CompletedPhase 2
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of IHBG-10 on Weight Loss and Body Composition
Avera McKennan Hospital & University Health Center2 sites in 1 country10 target enrollmentStarted: February 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Weight
Study Overview
Brief Summary
This is a pilot study to determine the safety and efficacy of an investigational product (IHBG-10) on weight loss, and changes in body composition.
Detailed Description
Subjects will be randomized to one of two groups: one group will take 500 mg of the investigational product (IHBG-10) 15 minutes prior to the three main meals of the day; the other group will take placebo 15 minutes prior to the three main meals of the day. Subjects will be on the investigational product or placebo for 12 weeks. Participation in this study involves four study visits.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 18 and older
- •Body mass index of 30 or greater
- •Agree to keep diet, exercise and all current health habits stable during participation in the study
Exclusion Criteria
- •Women who are pregnant, breastfeeding or planning to become pregnant
- •Prior bariatric surgery
- •Use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month
- •Obesity as a result of a clinically diagnosed endocrine problem
- •Currently taking an anti-psychotic medication
- •History of peptic ulcer disease
Outcomes
Primary Outcomes
Weight
Time Frame: 12 weeks
Secondary Outcomes
- Body composition(12 weeks)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 1
r-hLIF for Improving Embryo Implantation in IVFInfertility Implantation FailureNCT00504530Merck KGaA, Darmstadt, Germany50
Completed
Phase 2
MK0249 for the Symptomatic Treatment of Alzheimer's Disease (MK0249-011)Alzheimer's DiseaseNCT00420420Merck Sharp & Dohme LLC144
Not yet recruiting
Phase 1
A Study to Evaluate the Safety and Efficacy of GR2002 Injection in Patients With Atopic Dermatitis.Atopic DermatitisNCT06175143Genrix (Shanghai) Biopharmaceutical Co., Ltd.40
Completed
Phase 3
Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)Primary InsomniaNCT00094627H. Lundbeck A/S465
Completed
Phase 2
A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Persistent Asthma.AsthmaNCT00398645GlaxoSmithKline648