CagriSema REIMAGINE: First Phase 3 Data at ADA 2026 (Cagrilintide plus Semaglutide)

At the 2026 Scientific Sessions of the American Diabetes Association (ADA) in New Orleans, detailed Phase 3 results on CagriSema are on the program for the first time. Novo Nordisk announced the presentation on May 27, 2026. The centerpiece is a dedicated symposium on Sunday, June 7, 2026, that brings together the three studies REIMAGINE 1, 2 and 3. For everyone following the amylin analogue cagrilintide as a research substance, this is one of the most important data points of the year.

This article summarizes what the sources actually provide: the study design, the participant numbers, the doses tested, the endpoints, and the reported figures on blood glucose (HbA1c) and body weight. All details come from the official communications by Novo Nordisk, the ADA newsroom and the associated scientific publications. The focus is solely on the body of evidence, not on usage recommendations.

What CagriSema is and the role cagrilintide plays

According to Novo Nordisk, CagriSema is a fixed combination of two active ingredients in a single once-weekly subcutaneous dose: cagrilintide, a long-acting analogue of the hormone amylin, and semaglutide, a GLP-1 receptor agonist. The ADA newsroom describes cagrilintide as a long-acting analogue of amylin, a peptide hormone secreted together with insulin that has broad effects on satiety, gastrointestinal motility, glucagon secretion, as well as on bone, muscle, fat and the cardiovascular system.

The scientific rationale behind the combination is the idea of two distinct and potentially additive mechanisms of action: the amylin signal from cagrilintide plus the GLP-1 signal from semaglutide. It is precisely this interplay that the REIMAGINE studies examine.

For laboratory research, what matters is that cagrilintide is available as a single substance and was also run as a standalone comparator arm in the studies. We carry cagrilintide as a research peptide. Semaglutide is not part of our range here and is mentioned only as a study component.

Cagrilintidemetabolic

Long-acting amylin analog studied for once-weekly satiety and appetite control. Phase 3 REDEFINE trials complete, NDA filed with FDA December 2025. A mechanism distinct from GLP-1 agonists.

The REIMAGINE program: three studies, three patient groups

The REIMAGINE program tests CagriSema in adults with type 2 diabetes across different background therapies. The three studies cover different starting situations.

REIMAGINE 1 investigated CagriSema in 180 adults with type 2 diabetes who were not adequately controlled on diet and exercise alone. Here CagriSema was tested as monotherapy. One special feature of the design: at the end of the study, a twelve-week discontinuation phase was planned in order to assess treatment persistence and criteria for diabetes remission.

REIMAGINE 2 is the large study of the program with 2,728 adults. It enrolled people with type 2 diabetes who were not adequately controlled on metformin with or without an SGLT2 inhibitor (around 40 percent used an SGLT2 inhibitor). The study compared CagriSema against its single components (cagrilintide alone, two semaglutide doses) as well as against placebo.

REIMAGINE 3 evaluated CagriSema in 270 adults who were not adequately controlled on basal insulin with or without metformin. Here CagriSema was used as add-on therapy. According to the ADA newsroom, this arm showed stronger HbA1c reductions to below target levels, combined with substantial weight loss.

The reported figures from REIMAGINE 2

The most detailed figures so far come from REIMAGINE 2. Novo Nordisk reported the results for two statistical analysis frameworks that are common in such studies: the efficacy estimand (effect under planned use) and the treatment regimen estimand (effect regardless of treatment discontinuation or rescue medication).

Under the efficacy estimand, CagriSema 2.4 / 2.4 mg versus semaglutide 2.4 mg over 68 weeks showed:

• HbA1c reduction of 1.91 percentage points versus 1.76 percentage points under semaglutide 2.4 mg.
• Weight loss of 14.2 percent versus 10.2 percent under semaglutide 2.4 mg (starting from around 101 kg).
• 43 percent of participants achieved a weight loss of at least 15 percent, 24 percent of at least 20 percent.
• Through week 68, no plateau in the weight trajectory was observed.

Under the more conservative treatment regimen estimand, the HbA1c reduction was 1.80 percentage points (semaglutide 2.4 mg: 1.68 percentage points) and the weight loss was 12.9 percent (semaglutide 2.4 mg: 9.2 percent). Novo Nordisk describes the differences in favor of CagriSema as statistically significant.

On the safety profile: according to the communication, the most common adverse events under CagriSema were gastrointestinal in nature, which were overwhelmingly mild to moderate in severity and diminished over time. The press release did not state specific discontinuation rates due to adverse events.

Putting it in the context of earlier evidence

The REIMAGINE data continue a development line that is documented in the scientific literature. Two papers are helpful as reference points.

In the Phase 1b study (Enebo et al., Lancet 2021, PMID 33894838), the co-administration of multiple doses of cagrilintide with semaglutide 2.4 mg was investigated in otherwise healthy adults with a body mass index of 27.0 to 39.9 kg/m2. It was a randomized, placebo-controlled multiple-ascending-dose design with cagrilintide doses from 0.16 to 4.5 mg. After 20 weeks, the reported weight loss was up to 17.1 percent depending on the dose (in combination with semaglutide 2.4 mg). The combination was described as well tolerated with an acceptable safety profile.

In the later Phase 2 study in type 2 diabetes (Frias et al., Lancet 2023, PMID 37364590), 92 participants were randomized over 32 weeks to CagriSema (n=31), semaglutide (n=31) or cagrilintide (n=30). The mean HbA1c change under CagriSema was 2.2 percentage points (semaglutide 1.8; cagrilintide 0.9), and the mean weight change was 15.6 percent under CagriSema (semaglutide 5.1 percent; cagrilintide 8.1 percent). Gastrointestinal adverse events occurred in 58 percent of the CagriSema group, compared with 33 percent (cagrilintide) and 32 percent (semaglutide).

The REIMAGINE studies are thus the substantially larger Phase 3 successors to these early investigations. For the first time, they deliver more robust data on the combination, backed by larger patient groups.

The regulatory status: a US step, not an EU status

In parallel with the clinical development, there is a regulatory process that is often misinterpreted. On December 18, 2025, Novo Nordisk submitted a marketing application (New Drug Application) for CagriSema for weight management to the US Food and Drug Administration (FDA). The FDA review is expected over the course of 2026.

An important point for context: a submission is a regulatory procedural step in the US, not an approval. According to the manufacturer, CagriSema is approved neither in the US nor in the EU. A US approval procedure does not change the legal framework in Europe: cagrilintide remains a research substance for laboratory purposes here. What such announcements can actually shift is scientific and media interest, not the regulatory status for research in the EU.

Cagrilintide as a research substance

For laboratory research, the interesting component is the amylin analogue cagrilintide. In the REIMAGINE studies, as already in the early phases, cagrilintide was also run as a standalone comparator arm, which makes it clearly distinguishable as a research subject. Anyone who wants to study amylin biology independently of the GLP-1 axis thus has a defined single substance in front of them.

Cagrilintidemetabolic

Long-acting amylin analog studied for once-weekly satiety and appetite control. Phase 3 REDEFINE trials complete, NDA filed with FDA December 2025. A mechanism distinct from GLP-1 agonists.

Where it goes from here

The REIMAGINE symposium on June 7, 2026, bundles the three studies into a single session (Great Hall A, Ernest N. Morial Convention Center, chaired by John B. Buse, MD, PhD). With the presentation of the complete data sets, it is to be expected that further details on subgroups, the safety profile and the add-on results from REIMAGINE 3 will become public. Once the associated full-text publications are available, the press-release figures summarized here can be checked against the primary sources.

Note: This article is intended solely for scientific information. All substances mentioned are for research use only and not for human consumption.