Source: yimaitong
Key words: Semaglutide weight loss
Guide: step to evaluate the therapeutic effect of Semaglutide in obese population The results of the phase 3 study were released in the virtual meeting of obesity week 2020 held earlier this month: the data showed that the participants who also received intensive behavioral therapy lost 10.3% of the average weight in 68 weeks compared with the placebo group, and the weight loss effect of the somaluptide group was better than that of the currently approved weight loss drugs.
Lead researcher Dr. Walden said the drug could lead to a “potentially significant breakthrough” in obesity management.
Description of step 3 study
This is a 68 week randomized, double-blind, placebo-controlled trial involving 611 overweight / obese adult participants without diabetes (81% female; average age 46 years; 76.1% white;
average age 46 years, average BMI 38kg / m2), except for intensive treatment, participants were randomly treated with Semaglutide (2.4mg once a week) or placebo. Semaglutide was gradually increased to the target dose in the first 16 weeks, and then maintained at 2.4 mg for 1 year.
What is reinforcement behavior therapy? Provide no less than 14 times of behavior guidance within 6 months, and promote changes in diet and physical activity by monitoring the patient’s behavior (such as daily food and activity diary).
The average weight loss effect of such programs is 5% – 8% of the initial weight. If the frequency is low (such as once a month), the weight loss effect is usually only 1% – 3% of the initial weight.
All participants received a total of 30 intensive behavioral therapy sessions, each lasting 20-30 minutes, once a week for the first 12 weeks, every two weeks for the next 12 weeks, and then once a month to help participants adhere to their established diet / physical exercise goals:
➤ dietary goals: during the first eight weeks, participants were offered an alternative diet of 1000-1200 kcal / day, including liquid milkshakes, bars and prepared entrees to achieve more effective weight loss in the early stages. After that, the patients chose their own traditional food, and the energy intake was controlled within the range of 1200-1800 kcal / day according to the weight difference.
➤ sports goals: 100 minutes of walking or other aerobic exercise per week in the first month, and 200 minutes per week in the sixth month.
Test result
Weight loss: at week 68, the average weight loss of Semaglutide group was 16%, and that of placebo group was 5.7%. The former group lost 10.3% more weight (16% vs. 5.7%, 95% CI: – 12 ~ – 8.6; P < 0.0001).
In the Semaglutide group, 75.3% of the subjects lost more than 10% of the body weight during the trial, while only 27% of the placebo group; 55.8% of the Semaglutide group lost more than 15% of the weight, which was significantly better than 13.2% of the placebo group.
Comorbidity improvement: compared with placebo group, Semaglutide group also had greater improvement in complications, including waist circumference (estimated difference: – 14.6cm; 95% CI – 10.1 ~ – 6.6; P < 0.0001), HbA1c (estimated difference: – 0.24%; 95% CI) -29 ~ – 0.19; P < 0.0001), systolic blood pressure (estimated difference: – 3.9mmhg; 95% CI, – 6.4 ~ – 1.5; P < 0.01), diastolic blood pressure (estimated difference: – 2.2mmhg; 95% CI -3.9 ~ – 0.6; P < 0.01) and C-reactive protein (estimated difference: – 48%; 95% CI, – 55 ~ – 39; P < 0.0001).
Adverse reactions
In the Semaglutide group, the most common adverse events were gastrointestinal symptoms, including nausea, vomiting, diarrhea and constipation. 82.8% of participants reported these symptoms, mostly mild. In general, the safety results of 2.4mg Semaglutide were similar to those of 1mg Semaglutide and 3mg liraglutide.
“More effective than current FDA approved weight loss drugs”
Walden pointed out that Semaglutide has 10.3% more weight loss effect than placebo (about 10.6 kg), which is better than the current weight loss drug approved by FDA
➤ if you receive lifestyle counseling and use naltrexone bupropion, you will lose 5 kg more than receiving lifestyle counseling plus placebo;
➤ liraglutide 3.0mg was 5.3kg less than placebo;
➤ fentramine topiramate reduced 8.8 kg more than placebo.
Semaglutide is well tolerated. Although patients are likely to have gastrointestinal adverse reactions such as nausea, constipation and diarrhea, it can be controlled by slowly increasing the drug dosage within 4 months.
85% of patients with pre diabetes achieved remission, which was helpful to achieve happy weight loss
If the initial weight loss is less than 10% after intensive behavioral therapy or weight loss medication, the patient will usually feel dissatisfied.
What is impressive is that 75% of the patients in this study lost more than 10% of their body weight. Compared with the 5% – 10% weight loss of current behavioral / drug therapy, this degree of weight loss should better improve cardiac metabolic risk factors (such as hypertension, sleep apnea, and type 2 diabetes) and contribute to happy weight loss.
In addition, compared with placebo group, the number of participants who lost weight at baseline was significantly lower (P < 0.000 1%, P < 0.000 1%, P < 0.000 1%, P < 0.05).
From baseline to week 68, the proportion of patients with prediabetes in the Semaglutide group decreased from 48% to 7%, that is, about 85% of the patients achieved remission, while the placebo group decreased from 53% to 26%. The blood lipid of somaluptide group was also improved.
Promotion for weight loss? Compared with statins 30 years ago, there are still many problems to be solved
“The results are impressive and confirm that somaluptide is a very effective obesity management drug, especially when used in conjunction with professional counseling,” said Kahan, M.D., director of the National Center for weight and health in Washington, D.C. However, if it is promoted in the real world, some problems may be encountered.
“If the drug is approved for weight loss, the cost will be a major factor affecting its universal use.
This reminds me of the situation when lovastatin was first used in clinical practice in the late 1980s, when statins were still expensive, and there was not so much evidence of benefits today.
But as time went on, more and more evidence was available, and the cost gradually decreased. In the next 15 years, millions of people used lovastatin for primary prevention and secondary intervention of cardiovascular disease, It is not known whether GLP-1 receptor agonists will undergo a process similar to lovastatin.
In addition, another problem at present is that we need ‘hard endpoint data’ (e.g., three major cardiovascular adverse events) results before we can extend them to the whole population. ” Said Hirsch, a medical professor at the Wisconsin Institute of medical diabetes in Seattle, Washington.
reference material:
[1] Wadden TA. Semaglutide 2.4 mg and intensive behavioral therapy in subjects with overweight or obesity (STEP 3). Presented at: ObesityWeek Interactive; Nov. 5, 2020 (virtual meeting).
[2] https://www.medscape.com/viewarticle/940841#vp_3
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