Amgen Reports Promising Phase 2 Data on MariTide for Obesity, Type 2 Diabetes Management

Amgen announced today positive data from a 52-week phase 2 clinical trial of its investigational maridebart cafraglutide (MariTide) that showed substantial weight loss among people with obesity or overweight with or without type 2 diabetes (T2D) without plateaus.

Specifically, in participants with obesity or overweight without T2D, MariTide, formerly AMG 133, demonstrated up to approximately 20% average weight loss at week 52. In people with obesity or overweight with T2D, MariTide achieved up to approximately 17% average weight loss while also delivering significant improvements in glycemic control, with hemoglobin A1C (HbA1C) levels reduced by up to 2.2 percentage points at week 52. In both study populations, researchers did not observe a weight loss plateau, suggesting the potential for further weight loss beyond the study period, according to Amgen’s press release.

Beyond weight loss, MariTide demonstrated “robust and clinically meaningful improvements in cardiometabolic parameters,” Amgen noted in the release, including reductions in blood pressure, triglycerides, and high-sensitivity C-reactive protein (hs-CRP) levels across doses. Also, there were no significant increases in free fatty acids, and investigators did not observe any changes in bone mineral density among participants.

Amgen announced similar findings in February 2024 from a phase 1 trial, which suggested longer lasting and durable reductions in body weight with MariTide compared with other popular weight loss drugs on the market, including semaglutide and tirzepatide.

MariTide is a bispecific glucagon-like peptide 1 (GLP-1) receptor agonist and glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist. It is anticipated to be administered as a single dose in a handheld, patient-friendly, autoinjector device with a monthly or less frequent single-injection administration, according to the press release.

The new data showed that MariTide’s safety profile was consistent with its mechanism of action. The most common adverse events were gastrointestinal (GI)-related, such as nausea, vomiting, and constipation, which were primarily mild and transient. These symptoms were most often associated with the first dose and tended to resolve quickly, with nausea typically subsiding within 6 days and vomiting within 1 to 2 days. The incidence of these events was substantially reduced with dose escalation, and the discontinuation rate due to any adverse event was approximately 11%, with less than 8% related to GI issues. No new safety signals were identified.

"These results provide us confidence to initiate MARITIME, a Phase 3 program across obesity and a number of related conditions, providing a unique potential new treatment option for patients,” Jay Bradner, MD, executive vice president of Research and Development, chief scientific officer, Amgen, said in the press release.

Concurrently, an ongoing extension of the phase 2 study will explore the effects of MariTide beyond 52 weeks examine further weight loss with continued treatment, strategies for weight maintenance with less frequent or lower dosing, and the durability of weight loss following treatment discontinuation. The strong interest among participants is evident, with over 90% of eligible patients opting to continue into the study’s second phase.

Reference: Amgen announces robust weight loss with Maritide in people living with obesity or overweight at 52 weeks in a phase 2 study. News release. Amgen. November 26, 2024. Accessed November 26, 2024. https://www.amgen.com/newsroom/press-releases/2024/11/amgen-announces-robust-weight-loss-with-maritide-in-people-living-with-obesity-or-overweight-at-52-weeks-in-a-phase-2-study