Obesity is one of the most prevalent health problems and new treatment strategies are developing at a very fast pace. Looking at the market size of anti-obesity products, many anti-obesity agents are developed by Pharmaceutical and Food companies. These products have to undergo pre-clinical & clinical development processes to establish their safety & efficacy for human use.
There are various strategies to treat obesity which include:
- Appetite controlling
- Inhibiting Fat uptake
It becomes all the more important that the study protocol & its outcome must have clarity about the mechanism of the anti-obesity investigational product. Some of the following critical points one should keep in mind while designing its protocol.
- For clinical trials of anti-obesity agents, it becomes all the more important to have standardized protocol and meaningful endpoints.
- There should be clear instructions regarding diet, exercise, and other behavioral regimens.
- Lifestyle modifications are a must for the management of obesity and the clinical study protocol must have details of lifestyle counseling and their compliance during the study period. Lifestyle counseling by dieticians or health educators can add huge value to the study outcome and can benefit the sponsor.
- In obesity trials, the sequence of the food, like protein before fat and carbohydrate or vise-versa can change the outcome of the study and can impact product efficacy in a huge manner.
- Exercise such as walking and cycling extra can be added to the study protocol.
- Frequent follow up with the patient are important for better compliance of the patient. Initially, every two-week follow-up and then once four weeks follow-up is recommended for long-term anti-obesity studies.
- Subjects to be enrolled for initial clinical trials should have a BMI of 30 without co-morbid diseases.
- Subjects with histories of anorexia Nervosa or other extreme eating disorders should be excluded.
- The age range should be as wide as possible.
- Prior use of anti-obesity agents should be documented, and a subject should have been of any anti-obesity drug for at least 6 months.
- Subjects should have had a stable weight with changes of ~3 kg in the last 3 months to 6 months.
- Weight loss should be the primary outcome.
- Cardiovascular risk factors, such as blood pressure, serum glucose, lipids, uric acid, and other measures should be assessed as secondary outcomes.
- Dropouts should be minimized by appropriate strategies built into the protocol.