New Drugs — Does Lifestyle Intervention Still Count? Part 3

Moving on to tirzepatide, it is semaglutide mixed with another GLP-1 agonist. Under the brand name Mounjaro, it is currently approved only for type 2 diabetes, but is widely used “off-label” to achieve weight loss.

The SURMOUNT-1 trial included 2,539 adults without diabetes, but with at least one weight-related complication. After two weeks of screening, subjects were randomized into four sectors: the placebo group, of course, with the others receiving three different doses of tirzepatide. The substances were…

[…] administered subcutaneously once weekly for 72 weeks as an adjunct to lifestyle intervention. Lifestyle intervention included regular lifestyle counseling sessions, delivered by a dietitian or a qualified health care professional, to help the participants adhere to healthful, balanced meals, with a deficit of 500 calories per day, and at least 150 minutes of physical activity per week.

This is typical of such experimental explorations. The number and nature of counseling sessions may differ, or the amount of physical exertion asked for or performed may vary, but that seems to be about the extent of the lifestyle intervention. The effectiveness varies. One thing the researchers mention is…

[…] evidence that diet and exercise prompt physiological counterregulatory mechanisms that limit weight reduction and impede weight maintenance.

In other words, in many cases, even though patients work out and receive counseling, and astonishing new meds, of course, the body has its ways of fighting back in a stubborn effort to maintain its weight. The astute reader may guess that we will be making a point about all this: work on the head is also needed, and that is the ingredient that BrainWeighve provides.

Another news article concerns participants in two trials, SURMOUNt-3 and SURMOUNT-4, preceded by

[…] a 12-week intensive lifestyle intervention lead-in period that included exercise, low cal diet, and weekly counseling sessions during which candidates had to lose at least 5% of body weight.

So apparently, that is the definition of intensive. Still, no mention of self-management skills and other benefits available from a program like BrainWeighve.

In mid-October of this present year, the Lilly pharmaceutical firm prudently issued its
Cautionary Statement Regarding Forward-Looking Statements” aimed, it seems, at over-excited investors who tend to hear what they want to hear:

[A]s with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, that tirzepatide will receive additional regulatory approvals, or that tirzepatide will be commercially successful.

Your responses and feedback are welcome!

Source: “Tirzepatide Once Weekly for the Treatment of Obesity,”, 07/21/22
Source: “Eli Lilly’s tirzepatide aces 2 more late-stage obesity trials as FDA decision nears,”, 07/27/23
Source: “Lilly’s tirzepatide shows additional 21.1% weight loss after 12 weeks of intensive lifestyle intervention…,”, 10/15/23
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OVERWEIGHT: What Kids Say explores the obesity problem from the often-overlooked perspective of children struggling with being overweight.

About Dr. Robert A. Pretlow

Dr. Robert A. Pretlow is a pediatrician and childhood obesity specialist. He has been researching and spreading awareness on the childhood obesity epidemic in the US for more than a decade.
You can contact Dr. Pretlow at:


Dr. Pretlow’s invited presentation at the American Society of Animal Science 2020 Conference
What’s Causing Obesity in Companion Animals and What Can We Do About It

Dr. Pretlow’s invited presentation at the World Obesity Federation 2019 Conference:
Food/Eating Addiction and the Displacement Mechanism

Dr. Pretlow’s Multi-Center Clinical Trial Kick-off Speech 2018:
Obesity: Tackling the Root Cause

Dr. Pretlow’s 2017 Workshop on
Treatment of Obesity Using the Addiction Model

Dr. Pretlow’s invited presentation for
TEC and UNC 2016

Dr. Pretlow’s invited presentation at the 2015 Obesity Summit in London, UK.

Dr. Pretlow’s invited keynote at the 2014 European Childhood Obesity Group Congress in Salzburg, Austria.

Dr. Pretlow’s presentation at the 2013 European Congress on Obesity in Liverpool, UK.

Dr. Pretlow’s presentation at the 2011 International Conference on Childhood Obesity in Lisbon, Portugal.

Dr. Pretlow’s presentation at the 2010 Uniting Against Childhood Obesity Conference in Houston, TX.

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