Clinical Trial at Albany Med Contributes to FDA Approval for New GLP-1 Drug

When news broke that the FDA had approved Foundayo, a new GLP-1 pill for diabetes and weight loss that doesn’t need to be taken on an empty stomach, many people wanted to learn more.

But some Albany Medical Center patients were already familiar with it: They had taken the medication for more than a year as part of the clinical trial that led its approval by the FDA.

Early Access to Innovative Treatments

Each year, the Albany Med Health System participates in hundreds of clinical trials—studies with human volunteers that test groundbreaking new treatments and procedures for safety, efficacy, and long-term benefits and risks.

Endocrinologist Robert Busch, MD, has been enrolling patients for more than two decades in clinical trials for drugs to treat diabetes and complications from it, including heart disease, kidney disease, and eye diseases.

In 2024, he recruited 10 patients from the Capital Region for the randomized, double-blind Phase 3 clinical trial for Foundayo, designed to compare it with a placebo and to assess its effectiveness and side effects.

Life-Changing Treatment

The Foundayo trial was life-changing for at least one of Dr. Busch’s patients, who subsequently lost 60 pounds with only minimal side effects. (The average weight loss for people in the trial was 25 pounds.)

Before the clinical trial, this patient used to think about food all the time. But the drug, which, like other GLP drugs, works by suppressing hunger and slowing the digestive process, took away all the “food noise” in their head.

The patient experienced other benefits as well, including an increase in energy and being able to walk and accomplish daily tasks with more ease.

Future Clinical Trials

While the Foundayo trial is complete, Dr. Busch continues to recruit for other trials.

One current trial is studying an “attain and maintain” strategy. Patients start with GLP-1 injections until they lose 15 to 20 percent of their weight, then take a pill instead of the injections. The researchers will assess whether that approach enables patients to maintain their weight loss.

To inquire about participating in an upcoming endocrinology clinical trial, or to refer a patient as a possible participant, contact Dr. Busch at 518-489-4704.