Examining the Semaglutide Treatment Effect in People (STEP 1) trials for weight loss provides answers to many questions about this subject. With many companies in the pharmaceutical industry bustling to secure their place in what may well become a prominent drug market segment, understanding these trials becomes vital.
The trial was a randomized, double-blind, placebo-controlled trial, covering almost two thousand adults who were overweight or obese and without type 2 diabetes. Participants either received a once-weekly subcutaneous semaglutide (2.4 mg) or a placebo, along with lifestyle intervention. The first phase ran for 68 weeks, followed by seven weeks without treatment. Some participants continues in the trial for another 45 weeks.
The trials began in 2018, spanning over two and a half years, with the final report published in March 2021. The core objective was to determine the average weight gain or loss experienced by subjects administered with the drug semaglutide during these thirty months. Participants were adults with a body mass index (BMI) of 30 kg/m2 or higher, or 27 kg/m2 or higher with at least one weight-related health issue and a history of unsuccessful attempts at dietary weight loss.
All participants had to follow the same healthy diet and physical exercise routines. This was a “double-blind” study, meaning neither the participants nor the medical staff overseeing the trial knew whether a participant received the placebo or the actual drug.
The results speak for themselves:
| Control group (placebo) | Semaglutide 2.4 mg group | |
| Number of participants at the start | 655 | 1306 |
| Number of participants at the end | 609 | 1240 |
| Dosage by weekly subcutaneous injection
Starting at 0.25 mg, then incrementing every 4 weeks to doses of 0.5, 1.0, 1.7, and 2.4 mg/week |
Placebo | Semaglutide |
| Gender split | 74% female, 26% male | 76% female, 24% male |
| Percentage of subjects who lost at least 5% of body mass | 31.5% | 86.4% |
| Percentage of subjects who lost at least 10% of body mass | 12.0% | 69.1% |
| Percentage of subjects who lost 15% or more of body mass | 4.9% | 50.5% |
| Average reduction in waistline | 4.4 cm | 14.1 cm |
| Average weight loss | 2.9 Kg | 16.1 Kg |
You might ask why such an extensive trial was necessary. Drug trials are complex and expensive, and pharmaceutical companies typically undertake them with a strong belief that the outcome will be positive. This doesn’t imply that the results are manipulated or unreliable, despite occasional discussions suggesting such.
The main purpose of this trial by Novo Nordisk A/S was to identify the side effects of its product, Ozempic, which was released a few years earlier as a treatment for type 2 diabetes.
In the medical world, ‘side effects’ don’t always imply negative outcomes. Sometimes, patients report unexpected benefits during clinical trials or post-market release. One famous example involves Pfizer’s development of a drug called sildenafil in 1989. Initially intended to treat heart-related chest pain, it ended up being released as Viagra due to reported sustained penile erections in trial participants.
After the release of Ozempic for adult diabetes, consistent reports emerged about users losing weight during their treatment. The drug semaglutide slows down insulin release when blood sugar levels are high and makes people feel fuller by slowing stomach emptying, impacting appetite and food intake. Noticing this potential cause and effect, Novo Nordisk funded the STEP 1 study to ascertain if weight loss was a coincidental effect of Ozempic or if they had stumbled upon a potential weight-loss drug.
Did semaglutide prove effective for weight loss?
STEP 1 was a rigorous double-blind, placebo-controlled study to establish the weight loss effects of semaglutide. The results were indeed impressive, with a high percentage of participants experiencing significant weight loss and a reduction in waistline compared to the control group.
Interestingly, the STEP 1 program experienced a low dropout rate, with only 5% of those on semaglutide leaving the trial. This low percentage likely reflects the mild unwanted side effects of Ozempic and the visible and sustained improvements reported by participants.
Why are some people questioning whether semaglutide is the right treatment for them?
Since its approval by the FDA for weight loss, a few concerns about semaglutide have arisen. Questions have been raised about the sustainability of weight loss post-treatment and the high cost of the treatment, which most health insurers do not cover.
A study reported in the journal Diabetes Obesity and Metabolism revealed that participants regained two-thirds of their prior weight loss a year after the withdrawal of semaglutide, indicating the need for ongoing treatment to maintain weight loss and health improvements.
Until health insurers add semaglutide and similar GLP-1 receptor agonist drugs to their cover, the cost of the drug remains an issue for everyone. However, in comparison to the average price for the four-week 0.25 mg injection from US pharmacies which is currently $1,718.50, here at IsraelPharm, we can provide the same dose of Ozempic for just $550, shipped to you for free.
It is important to note that the high cost of semaglutide for weight loss has been a primary reason for people discontinuing the treatment program.
Why did Ozempic get such a bad reputation?
Ozempic was first developed to help people manage type 2 diabetes. It later gained attention for something very different: dramatic weight loss. While this has brought a lot of interest, it’s also led to negative publicity. So, why has Ozempic ended up with such a bad reputation?
Some of the criticism stems from misunderstandings, others from very real side effects. People have raised concerns about things like a tired, aged look known as Ozempic face, unexpected weight regain known as the bounce back, and even a trend of public Ozempic shaming. Social media hasn’t helped either, where the medication has become both a punchline and a headline.
But behind the noise is a medication that has been shown to help manage serious conditions like diabetes and obesity. The questions below look at what terms like Ozempic face and bounce back really mean, and how in most cases the answers to the common critical questions go to prove that the come largely from a misunderstanding of what Ozempic is and how it works, rather than any fundamental problem that could be coming from proper treatment with the medication.
Is semaglutide bad for the heart?
No. In fact, studies show that semaglutide lowers the risk of major heart problems in people with type 2 diabetes. The FDA has approved it for reducing the risk of heart attack and stroke in people who already have cardiovascular disease. That said, people with serious heart rhythm issues or a history of pancreatitis should talk to a doctor before using it.
Does semaglutide cause hair loss?
Hair loss isn’t a direct side effect of semaglutide, but some people report it. Rapid weight loss can sometimes lead to temporary hair thinning. This can happen with any dramatic diet or weight change, not just with medications. The hair usually grows back within a few months.
Does semaglutide mess up gut health?
Semaglutide slows down digestion, which is part of how it works. This can lead to bloating, constipation, or nausea, especially early on. It doesn’t harm the gut long-term for most people, but it can be uncomfortable in the first few weeks of treatment.
Why do I feel so bad on semaglutide?
Some people feel tired, nauseated, or bloated when they start taking semaglutide. These symptoms usually go away after a few weeks as the body adjusts. Eating smaller meals and avoiding high-fat foods can help. If symptoms persist, it’s important to speak with a healthcare provider.
What is the Ozempic face?
“Ozempic face” refers to sagging or hollowing of the face that can happen after quick weight loss. The loss of fat from the cheeks or jawline can make the face appear older or gaunt. It’s not dangerous, but some people find it upsetting. Dermatologists may offer cosmetic treatments if it becomes a concern.
Why would someone be ashamed of using semaglutide to lose weight?
This a a question that relates more to social issues than to medical treatment. When people are looked down on or judged by others for their excess weight, that’s weight stigma. The flip side of that coin is that if a person had to resort to “artificial tools” in order to lose some weight, rather than doing it via the old-fashioned “self denial and hard work” regimen, then they are weak, and can be subjected to Ozempic shame. The whole process has been reinforced by popular media personalities either refusing to “admit” that they used Ozempic to shed some excess pounds, or some visibly overweight stars sayins thing like “I would never use something like Ozempic to lose weight!”
The end result of all of this is that many people feel guilty for even thinking about using the potent weightloss tools that can now help them, and so don’t ask their doctor or pharmacist for proper guidance that can lead them to a sustainable and healthy solution.
