Diabetes Dialogue: ADA 2025 Preview

With a number of late-breaking presentations and high-profile phase 2 and 3 trials, the 2025 American Diabetes Association (ADA) Scientific Sessions reflect how rapidly the treatment landscape for obesity and diabetes is evolving. This year’s meeting, held June 20–24 in Chicago, will showcase significant updates on combination therapies, once-weekly insulin regimens, and novel mechanisms that may redefine standards of care for both type 1 and type 2 diabetes.

Among the highlights: new efficacy and safety data for GLP-1–based therapies, novel amylin analog combinations, and once-monthly treatment options signal a shift toward personalization and convenience in metabolic care.

In this special episode of Diabetes Dialogue cohosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, preview the most anticipated data, explore clinical implications, and discuss what may come next in the exciting pipelines for diabetes and obesity.

During the meeting, Isaacs will also participate in a debate on over-the-counter continuous glucose Monitoring with David Ahn, MD, of Hoag, on Friday, June 20, and Bellini will chair 2 sessions, “Real-World Automated Insulin Delivery System Results” on June 20, and “Advances and Trends in Diabetes Technology” on June 22.

Diabetes Dialogue: Trials to Watch at ADA 2025

Once-Monthly MariTide for the Treatment of Obesity in People With or Without Type 2 Diabetes—A 52-Week Phase 2 Study

Presentation Time: Monday, June 23, 2025, from 1:30-3:00 pm CDT
Presenter: Ania M. Jastreboff, MD, PhD, of Yale University
Summary:

In the last few years, the emergence of highly effective incretin-based therapies such as glucagon-like peptide 1 (GLP-1) receptor agonists (RA) has transformed obesity care. A new contender in the GLP-1 RA field is maridebart cafraglutide, or MariTide, which is being evaluated in a phase 2 study.

The study enrolled 592 adults into 2 cohorts with or without type 2 diabetes (T2D) and Amgen previously shared pooled data from the study demonstrating an average weight loss of around 17% without a plateau. During the ADA SciSessions, Jastreboff will present the unpooled data for each of the treatment arms in people with obesity and details of cardiometabolic measures for people with and without T2D for the first time.

Treatment of Hypercortisolism in People with Difficult-to-Control Type 2 Diabetes—Final Results of the CATALYST Trial

Presentation Time: Monday, June 23, 2025, from 3:15-4:15 pm CDT
Presenter: Vivian Fonseca, MD, of Tulane University
Summary:

During last year’s SciSessions, Fonseca and colleagues presented data highlighting the prevalence of hypercortisolism in people with difficult-to-manage T2D – which was a surprising 24% of the 1055 participants enrolled in the first phase of the CATALYST trial.

At this year’s meeting, the investigators return to present the efficacy and safety of the glucocorticoid receptor modulator mifepristone in participants with hypercortisolism and difficult-to-manage T2D in the second phase of the Corcept Pharmaceuticals-sponsored trial. The new data, investigators say, support a paradigm shift in diabetes care to screen for and treat hypercortisolism as an approach to improve glycemic control.

Can We Improve the Quality of Weight Loss by Augmenting Fat Mass Loss While Preserving Lean Mass? The BELIEVE Study of Bimagrumab + Semaglutide

Presentation Time: Monday, June 23, 2025, from 8:00-9:30 am CDT
Presenter: Steven B. Heymsfield, MD, of Pennington Biomedical Research Center
Summary:

Although GLP-1 RAs such as semaglutide become more prevalent in treatment strategies for weight loss, questions remain as to the potential merit of combination therapy vs monotherapy. The phase 2 BELIEVE trial of bimagrumab plus semaglutide versus bimagrumab monotherapy sought to answer this question and theorized that the addition of bimagrumab will preserve lean mass in study participants.

Heymsfield will present efficacy and safety data from the trial, which enrolled 500 participants at 26 centers across the United States with baseline BMI of≥30 or≥27 with obesity-associated comorbidities and obesity refractory to at least 1 behavioral attempt to lose body weight. The primary outcome is change in body weight and secondary outcomes include change in waist circumference, change in BMI, change in percent body fat, change in visceral and subcutaneous adipose tissue, change in trunk fat mass, percentage of weight loss due to fat mass or lean mass, quality of life, and more.

Evolving Role of GLP-1 RA and New Insights from the STRIDE Trial

Presentation Time: Saturday, June 21, 2025, from 1:30-3:00 pm CDT
Presenter: Subodh Verma, MD, PhD, FRCSC, of St. Michael's Hospital
Summary:

In recent years, semaglutide has taken on a lead role in revolutionizing the role of GLP-1 receptor agonists in care for weight loss, diabetes, cardiovascular risk reduction in adults with T2D and known heart disease, and worsening kidney disease and cardiovascular death risk reduction in people with chronic kidney disease and T2D.

Another indication that seems poised to add to the mix is peripheral artery disease (PAD) with T2D. Funded by Novo Nordisk, STRIDE was launched in 2020 as a double-blind, randomized, placebo-controlled trial done at 112 outpatient clinical trial sites in 20 countries in North America, Asia, and Europe. The trial enrolled adults with PAH and T2D evaluating a primary outcome of the ratio from baseline of the maximum walking distance at week 52, measured on a constant load treadmill. The trial has randomized 792 participants 1:1 to placebo or semaglutide. Key efficacy, epidemiology, and biomarker data from the trial will be presented.

Efficacy and Safety of CagriSema 2.4mg/2.4mg in Adults with Overweight/Obesity—The REDEFINE 1 and REDEFINE 2 Clinical Trials

Presentation Time: Sunday, June 22, 2025, from 8:00–9:30 am CDT
Presenter: W. Timothy Garvey, MD, of University of Alabama at Birmingham; Melanie J. Davies, MB, ChB, MD, University of Leicester; and Sue D. Pedersen, MD, of University of Calgary
Summary:

Another clinical trial program seeking to investigate potential combination therapies with semaglutide is the REDEFINE program, which is evaluating semaglutide and long-acting amylin analogue cagrilintide combination therapy (termed CagriSema) in people who are overweight/obese with or without T2D. The program, sponsored by NovoNordisk, consists of REDEFINE 1 in individuals without T2D, and REDEFINE 2 in individuals with T2D. Both populations have demonstrated notable weight loss after 68 weeks.

During the meeting, Garvey will break down the topline efficacy results of REDEFINE 1 and Davies will detail efficacy findings in REDEFINE 2 including continuous glucose monitoring (CGM), time in range (TIR), A1C, and other secondary endpoints. Furthermore, Pedersen will detail safety findings.

Advancing and Facilitating Basal Insulin Therapy in Type 2 Diabetes—Breaking News on the QWINT 1, 3, and 4 Trials with Once-Weekly Insulin Efsitora Alfa!

Presentation Time: Sunday, June 22, 2025, from 1:30–3:00 pm CDT
Presenter: Chantal Mathieu, MD, PhD, of Katholieke Universiteit Leuven; Athena Philis-Tsimikas, MD, of Scripps Research Translational Institute; and Julio Rosenstock, MD, of University of Texas
Summary:

The QWINT program, sponsored by Eli Lilly, is investigating weekly dosing of basal insulin compared to daily dosing, which could ease treatment burden in patients with T2D. The program consists of QWINT-2, which previously demonstrated safety and efficacy of insulin efsitora alfa; QWINT-1, which is evaluating a new approach to basal insulin dose escalation in patients with insulin-naïve T2D; QWINT-3, which is comparing insulin efsitoria as a weekly basal insulin with insulin degludec in participants with T2D currently treated with basal insulin; and QWINT-4, which is tracking patients with insulin-experienced T2D taking both bolus and mealtime insulin. The latest findings will be presented at Scientific Sessions from QWINT-1, 3, and 4.

ADJUnct Semaglutide Treatment in Type 1 Diabetes (ADJUST-T1D) Trial Outcomes

Presentation Time: June 23, 2025, from 3:15-4:15 pm CDT
Presenter: Davida F. Kruger, of Henry Ford Health
Summary:

Current approved use of semaglutide is limited to patients with T2D and is currently only off-label for people with T1D. The ADJUST-T1D trial seeks to formally evaluate the therapy’s efficacy in people with T1D and obesity, using FDA-approved hybrid closed-loop therapies.

The trial’s primary outcome is the proportion of adults with T1D achieving a composite outcome of CGM-measured TIR 70% with time below range of <4% and reduction in body weight by 5% at 26 weeks in the semaglutide group compared to placebo group. Secondary outcomes include other biomarkers and CGM measures. Kruger will present topline data during the meeting.