Conference Recap: American Diabetes Association 85th Scientific Sessions

Key Takeaways

CagriSema led to significant weight loss and metabolic improvements in individuals with overweight or obesity, outperforming semaglutide, cagrilintide, and placebo.
Participants in REDEFINE 2 with type 2 diabetes showed notable weight loss, glycemic improvements, and enhanced cardiovascular risk markers.
Semaglutide improved walking outcomes and quality of life in individuals with type 2 diabetes and PAD, reducing disease progression risk by 54%.
Benefits of semaglutide were independent of baseline hemoglobin A1C levels, diabetes duration, treatment intensity, body mass index, or SGLT2 inhibitor use.

Combination Bimagrumab, Semaglutide Enhances Fat Loss and Muscle Preservation

In the randomized double-blind, placebo-controlled, multicenter BELIEVE trial (NCT05616013), bimagrumab (Eli Lilly and Co)—a drug indicated to combat muscle loss—combined with semaglutide (Ozempic, Wegovy; Novo Nordisk) led to greater fat loss and improved muscle retention than either treatment alone.^1,2 In the BELIEVE clinical trial, researchers evaluated the effects of bimagrumab alone and in combination with semaglutide in adults with overweight or obesity. A total of 507 individuals were randomly assigned to receive semaglutide as a once-weekly subcutaneous injection and/or bimagrumab via intravenous infusion at weeks 4, 16, 28, and 40.^1,2 Presenter Penelope Montgomery, MD, of Optimal Clinical Trials, said the primary endpoint was change in body weight from baseline, with secondary endpoints including changes in waist circumference, total body fat mass, visceral adipose tissue, and lean mass.^1,2 The results demonstrated that the combination therapy led to greater reductions in weight, total and visceral fat, and markers of inflammation compared with either treatment alone. Notably, 92.8% of the total weight loss from the combination therapy came from fat mass, compared with 71.8% with semaglutide alone. When bimagrumab was used as a monotherapy, 100% of weight loss was attributed to fat mass, and there was a 2.5% increase in total lean mass.¹The breakthroughs presented in the BELIEVE clinical trial highlight a new path forward in obesity treatment by focusing on the quality—not just quantity—of weight loss.

CagriSema Demonstrates Significant Weight Loss in Clinical Trials

In the Phase 3 randomized, double-blind, multicenter, placebo-controlled REDEFINE 1 (NCT05567796) and REDEFINE 2 (NCT05394519) clinical trials, conducted over 68 weeks, CagriSema (Novo Nordisk)—a once-weekly combination therapy of semaglutide and cagrilintide, an amylin analog—demonstrated significant weight loss and metabolic improvements compared with placebo.^1,2

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REDEFINE 1 evaluated the efficacy and safety of once-weekly CagriSema in individuals with overweight or obesity over 68 weeks. Baseline characteristics included a mean body weight of 106.9 kg, a mean body mass index of 37.9 kg/mÇ, a waist circumference of 114.7 cm, and a hemoglobin A1c (HbA1c) of 5.5%. Primary endpoints included relative body weight change at 68 weeks and the proportion of participants achieving 5% or more weight loss.^1,2

CagriSema produced clinically meaningful and sustained weight loss compared with semaglutide alone, cagrilintide alone, or placebo. Participants receiving CagriSema were more likely to achieve 5% or higher, 20% or higher, and 30% or higher weight reduction and experienced improvements in blood pressure, glycemic control, and lipid profiles.¹

REDEFINE 2 focused on individuals with overweight or obesity and type 2 diabetes. Findings showed that CagriSema led to significant and clinically relevant weight loss, glycemic improvements (including HbA1c and continuous glucose monitor metrics), and near-normoglycemic control. Participants also showed improvements in cardiovascular risk markers and physical function.¹

“These are spectacular results,” presenter Louis J. Aronne, MD, FACP, DABOM, said. “I keep hearing people talk about best in class. This is now right there as best in class.”¹

Semaglutide Improves Mobility for Patients With Diabetes and PAD

In the Phase 3, multinational, double-blind, randomized STRIDE clinical trial, semaglutide (Ozempic, Rybelsus, Wegovy; Novo Nordisk), a glucagon-like peptide-1 receptor agonist, showed potential in managing peripheral arterial disease (PAD) among individuals with type 2 diabetes (T2D).

A total of 792 individuals (median age 68 years; 25% female) with T2D and PAD presenting with intermittent claudication were randomly assigned to receive either semaglutide (n = 396) or placebo (n = 396) over 52 weeks.^1,2

The results demonstrated that semaglutide significantly improved walking outcomes, enhanced quality of life, and reduced the risk of disease progression by 54%. At week 52, the estimated median ratio to baseline in maximum walking distance was 1.21 in the semaglutide group vs 1.08 in the placebo group.^1,2

Importantly, benefits were observed independently of baseline hemoglobin A1C levels, diabetes duration, treatment intensity, body mass index, or concurrent use of sodium-glucose cotransporter-2 (SGLT2) inhibitors.^1,2