ADA 2025 Late-Breaking Trials Preview

The 2025 American Diabetes Association (ADA) Scientific Sessions aim to capture the accelerating pace of innovation in diabetes and obesity care. Following a year marked by major clinical milestones, this year’s meeting, taking place June 20–24 in Chicago, brings forward a wave of late-breaking data and pivotal phase 2 and 3 trial results that could reshape treatment standards across the metabolic disease spectrum.

As part of ADA 2025, the program includes multiple late-breaking sessions featuring key updates on GLP-1–based therapies, once-weekly insulin regimens, amylin analog combinations, and emerging agents with novel mechanisms. Presentations at the meeting highlight a growing shift toward more personalized, durable, and patient-friendly approaches in both type 1 and type 2 diabetes management. Check out our overview of the top 7 studies being presented during late-breaking clinical trial sessions at ADA 2025.

ADA Late-Breaking Clinical Trials

1. First Report of a Phase 3 RCT of Orforglipron, a Small Nonpeptide GLP-1RA, as Monotherapy in Drug-Naïve Type 2 Diabetes with Inadequate Glycemic Control—The ACHIEVE-1 Trial

Presentation: Saturday, June 21, 2025, from 8:40-9:00 CDT
Presenter: Julio Rosenstock, MD, of Velocity Clinical Research at Medical City Dallas

Summary:
Orforglipron is the first oral small molecule GLP-1 RA taken without food and water restrictions to successfully complete a Phase 3 trial. Eli Lilly previously announced that the trial, named ACHIEVE-1, met its primary endpoint, lowering A1c by an average of 1.3–1.6% from a baseline of 8.0% using the efficacy estimand in adults with type 2 diabetes (T2D) inadequately controlled by diet and exercise. More detailed data will be presented at the meeting.

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

Presentation: Sunday, June 22, 2025, from 8:00–9:30 am CDT
Presenters: 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:
The REDEFINE program evaluating semaglutide and long-acting amylin analogue cagrilintide combination therapy (termed CagriSema) in people who are overweight/obese with or without T2D. During the meeting, Garvey will break down the topline efficacy results of REDEFINE 1 in people without T2D, Davies will detail efficacy findings in REDEFINE 2 in people with T2D, including continuous glucose monitoring (CGM), time in range (TIR), A1C, and other secondary endpoints, and Pedersen will detail safety findings.

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

Presentation: Monday, June 23, 2025, from 1:30-3:00 pm CDT

Presenter: Ania M. Jastreboff, MD, PhD, of Yale University

Summary:

Maridebart cafraglutide, or MariTide, is a new GLP-RA being evaluated in a phase 2 study. Amgen previously shared pooled data from the study demonstrating an average weight loss of around 17% without a plateau. Unpooled data for each of the treatment arms in people with obesity and details of cardiometabolic measures for people with and without T2D will be presented for the first time.

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

Presentation: June 23, 2025, from 3:15-4:15 pm CDT

Presenter: Davida F. Kruger, of Henry Ford Health

Summary:

On-label use of semaglutide is currently limited to patients with T2D. The ADJUST-T1D trial is evaluating the therapy’s efficacy in people with T1D and obesity, using FDA-approved hybrid closed-loop therapies. The trial is primarily assessing a composite outcome of CGM-measured TIR 70% with time below range of <4% and reduction in body weight by 5% at 26 weeks compared to placebo.

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

Presentation: 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 seeks to combine semaglutide’s efficacy with bimagrumab to preserve lean mass.

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

Presentation: Monday, June 23, 2025, from 3:15-4:15 pm CDT

Presenter: Vivian Fonseca, MD, of Tulane University

Summary:

Following findings of the newfound prevalence hypercortisolism in people with difficult-to-manage T2D, the second phase of the CATALYST trial is evaluating the efficacy and safety of the glucocorticoid receptor modulator mifepristone in participants with hypercortisolism and difficult-to-manage T2D. Fonseca will present final data from the trial at the meeting.

7. 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: Sunday, June 22, 2025, from 1:30–3:00 pm CDT

Presenters: 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:

QWINT-1 is evaluating a new approach to basal insulin dose escalation in patients with insulin-naïve T2D QWINT-3 is comparing insulin efsitoria as a weekly basal insulin with insulin degludec in participants with T2D currently treated with basal insulin, and QWINT-4, is tracking patients with insulin-experienced T2D taking both bolus and mealtime insulin.