At the American Diabetes Association's Scientific Sessions, Mass General Brigham researcher Vanita Aroda, MD, presented results from SOLSTICE, a phase 2b randomized, placebo-controlled clinical trial evaluating the oral GLP-1 receptor agonist elecoglipron. The findings were published simultaneously in The Lancet.

The study found that elecoglipron significantly lowered blood glucose levels and reduced body weight in people with type 2 diabetes. Researchers say the results highlight the growing potential of oral GLP-1 medications to address some of the limitations associated with current treatment options.

Oral GLP-1 Treatment Shows Promise

"Our study's findings underscore the expanding potential of oral GLP-1 receptor agonists for people with type 2 diabetes," said Aroda, who serves as Director of Diabetes Clinical Research in the Division of Endocrinology, Diabetes & Hypertension within the Mass General Brigham Department of Medicine.

"To date, GLP-1 therapies have largely been limited to injectable or oral peptide formulations, each with inherent delivery and dosing constraints. Rigorous clinical trials like SOLSTICE can help us evaluate oral medications that may be just as effective for patients with diabetes while overcoming these limitations."

Elecoglipron was developed specifically for the treatment of type 2 diabetes. Most currently available GLP-1 medications are given through subcutaneous injection. While semaglutide is available as an oral option for people with type 2 diabetes, it must be taken first thing in the morning on an empty stomach, and patients must avoid food and water for 30 minutes afterward. Another oral non-peptide GLP-1 medication, orforglipron, has been approved in the United States for weight management.

SOLSTICE Trial Results

Sponsored by AstraZeneca, the SOLSTICE trial enrolled 406 adults with type 2 diabetes across nine countries, including the United States. Participants were randomly assigned to different treatment groups, allowing researchers to evaluate a range of starting doses, dose-escalation approaches, and maintenance doses.

After 26 weeks of treatment, elecoglipron lowered glucose levels significantly more than placebo across all tested doses.

Up to 89.6% of participants receiving the medication achieved an HbA1c level of 7% -- the standard target goal for average blood glucose levels over the past two to three months for most adults with diabetes. By comparison, 24.9% of participants in the placebo group reached that target.

The drug also produced meaningful weight loss. Up to 72.3% of people taking elecoglipron achieved at least a 5% reduction in body weight, compared with 20.2% of those receiving placebo.

Researchers reported that the medication's safety and tolerability profile was generally consistent with other GLP-1 therapies at this stage of development.

Additional Diabetes Research Presented

Aroda also serves as principal investigator for REIMAGINE 1, a randomized controlled trial evaluating CagriSema, a combination therapy that pairs the amylin receptor agonist cagrilintide with injectable semaglutide.

Results from that study were also presented at the ADA meeting and published in The Lancet Diabetes and Endocrinology. The trial showed positive outcomes, with up to 87% of participants reaching the target HbA1c level of 7%.

"At the center of every one of our clinical trials is the goal of improving outcomes for patients," said Aroda. "The studies being presented at this year's meeting highlight how essential carefully designed trials are for evaluating new therapies, refining existing approaches, and ensuring that advances in science translate into safer, more effective care for people living with diabetes."

Authors, Disclosures, and Funding

In addition to Aroda, the study authors include Melanie J Davies, Jill Maaske, Marcus Millegård, Víctor López Juan, Jens Aberle, Andreea Ciudin, Rory J McCrimmon, Olof Eklund, Judy L Shih, Mikaela Sjostrand, Donna Zarzuela, and Julio Rosenstock.

Aroda reports institutional contracts from Amgen, Applied Therapeutics, AstraZeneca, Biomea, Boehringer Ingelheim, Corcept, Eli Lilly, Fractyl, Kailera, Novo Nordisk, Pfizer, Recordati, Rhythm and Servier, as well as consulting fees from Baim Institute for Clinical Research, Mediflix, Sanofi, and Roche. Additional author disclosures are available in The Lancet.

The research was funded by AstraZeneca.