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MedStar Health Research Institute is among the leading research organizations participating in a large, double-blind, placebo-controlled Phase III study of a new GLP1-RA medication’s effects on weight loss.
There’s a stubborn myth that patients’ actions alone are responsible for causing them to be overweight and obese. Society often shames patients, suggesting that a lack of self-control or laziness brings on the condition. But the explanation is rarely that simple—obesity and overweight are chronic, multifactorial conditions that, over time, become nearly impossible for patients to cure on their own.
MedStar Health Research Institute is participating in an extensive study of a new drug to learn if it is effective in helping patients manage their weight.
The Phase III double-blind, placebo-controlled ATTAIN-1 clinical trial is enrolling 3,000 patients at hospitals nationwide to examine the effectiveness and safety of a pill called Orforglipron, a member of a class of drugs called glucagon-like peptide-1 receptor agonists (GLP-1 RA).
Orforglipron and other GLP-1 RAs, such as Ozempic and Saxenda, treat type 2 diabetes and obesity. Others like Trulicity and Byetta are approved for diabetes treatment only. The ATTAIN-1 study examines Orforglipron’s effects on obesity, which is reaching epidemic proportions in the U.S.—nearly 42% of U.S. adults had obesity from 2017 to 2020, up from 30.5% in 2000. That’s more than 100 million adults plus another 14.7 million children. Obesity plays an influential role in many serious diseases, including:
- Heart disease
- Stroke
- Type 2 diabetes
- Several types of cancer
Recently published results in the New England Journal of Medicine showed that Orforglipron helped patients with overweight or obesity reduce their weight by an average of 14.7% in only 32 weeks, with side effects similar to other GLP-1 RAs. Previously approved medications in this group help patients achieve a 5-10% reduction in body weight.
If our study shows similar results, Orforglipron could be another effective option to help patients manage their weight, especially those uncomfortable with injections. By demonstrating that overweight and obesity are treatable conditions with little to do with willpower, these medications can help combat stigma impacting millions of patients’ quality of life.
How GLP-RA1s work.
GLP-1 RAs are effective at helping people control blood sugar and manage weight when combined with diet and exercise. These medications mimic the action of the glucagon-like peptide-1 hormone, which is central to regulating both appetite and blood sugar levels. The medicine works in three ways:
- Boosts insulin production: Insulin is released after a meal when your blood sugar is high. GLP-1 RAs help the body produce more insulin.
- Less sugar released by the liver: The liver can add sugar to the bloodstream as needed. GLP-1 RAs help regulate this function.
- Slows down digestion: When the stomach empties more slowly, the nutrients in food are released more slowly, too. This prevents blood sugar from getting too high after a meal.
Most GLP-1 RAs on the market are taken with an injection under the skin of the stomach, upper arm, or thigh. One formulation of Semaglutide (marketed as Rybelsus) is the only GLP-1 RA taken as a single daily pill. Still, it is approved only for type 2 diabetes and must be taken on an empty stomach to be effective. Orforglipron is also a pill but it can be taken with or without food.
GLP-1 RAs are proven to lower blood sugar levels and help patients control diabetes and lose weight when combined with diet and exercise. Studies have shown that heart health and kidney function also can improve with these medications.
GLP-1 RAs are unlikely to cause low blood sugar or hypoglycemia. Possible side effects are usually mild and temporary and can include:
- Diarrhea
- Feeling full early in a meal
- Lower appetite
- Nausea
- Vomiting
Related reading: How GLP-1 RA Medications Can Help Manage Diabetes and Weight Loss.
Who is eligible for the ATTAIN-1 clinical trial?
Participants must be 18 or older, have a body mass index greater than 30 kilograms per square meter or 27 kilograms per square meter, and have a weight-related condition such as:
- High blood pressure
- Dyslipidemia (abnormal levels of fats in the bloodstream)
- Obstructive sleep apnea
- Cardiovascular (heart & blood vessels) disease
Patients will be randomly assigned to one of four groups. One of these groups will get a placebo, and the other three will get different doses of Orforglipron. All patients will eat a healthy diet and follow an exercise plan. We’ll track participants for 72 weeks to measure changes in their body weight and other metrics such as their waist measurement, blood pressure, and cholesterol.
Participants will be carefully screened upon enrolling. Those with prediabetes will be followed for 176 weeks to learn whether Orforglipron might prevent the progression of diabetes.
Flipping the script on obesity.
Helping our patients with obesity lose weight is an essential goal because so many serious health conditions can come with elevated weight. Obesity can interfere with physical health and impact your mental and behavioral health, self-image, and quality of life.
Medicines like GLP-1 RA, and their popularity are helping reshape our understanding of what it means to have a hormone-related condition like obesity. Scientists have developed several popular, effective drugs to help patients manage weight, none related to willpower or motivation.
I hope these pharmaceutical advances help us understand that obesity is a health condition like any other, and patients deserve our best empathetic care. I believe these medicines can also help our patients develop a new relationship with food and their bodies that can lead to significant advances in health.
Working toward better health for all.
At MedStar Health Research Institute, we participate in studies like this to help make our neighbors, communities, and society healthier. Specifically, studies like ATTAIN-1 help us support advances in therapies that benefit patients with endocrine and metabolic challenges like diabetes and obesity.
I’m proud to promote equitable research as we work to confront generational trauma and stigma so more people in our community can access the latest advances in medical care sooner.
When our research is more diverse, we can better understand how drugs like Orforglipron might benefit all patients. When it comes to diabetes, for instance, rates are about 1.5 times higher among historically minoritized groups, but I’ve seen many studies enroll 90% of white participants. We can and must do better.
As a clinical researcher, I’m in the enviable position of being able to investigate the best ways to care for my patients. My expert team and I get to help build new understanding and advance care from clinical trials to the clinic. We develop strong relationships with our patients, many of whom return again and again to participate in multiple studies.
I’m optimistic about our ability to deliver ever higher quality care to all patients, in part because medicines like GLP-1 RAs are helping them turn the tide against obesity and live longer, healthier lives in the process.
