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Novo's CagriSema Outshines Zepbound in Key Phase III Weight-Loss Study
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Key Takeaways
Novo's CagriSema delivered 12.4% weight loss versus 9.1% for LLY's tirzepatide in REIMAGINE 5.
CagriSema reduced HbA1c by 1.71% versus 1.67% for tirzepatide, meeting non-inferiority criteria.
CagriSema produced 21% weight loss versus 2% for placebo in REDEFINE 9 at week 68.
Novo (NVO - Free Report) announced top-line results from two phase III studies evaluating once-weekly CagriSema, its investigational fixed-dose combination of cagrilintide and semaglutide, in obesity and type II diabetes (T2D). In the REIMAGINE 5 study, CagriSema 1.0 mg/1.0 mg delivered superior weight loss versus tirzepatide 5 mg while achieving a non-inferior reduction in HbA1c in adults with T2D. Tirzepatide is the active ingredient in Eli Lilly’s (LLY - Free Report) Zepbound and Mounjaro, which are marketed for chronic weight management and T2D, respectively. The findings add to the clinical evidence supporting CagriSema as Novo advances its next-generation obesity and diabetes portfolio.
The latest data are particularly relevant to the competitive incretin market, where Novo and Lilly are developing and commercializing therapies designed to produce meaningful weight loss alongside metabolic benefits. CagriSema combines two mechanisms in a single once-weekly treatment, pairing cagrilintide, a long-acting amylin receptor agonist, with semaglutide, a GLP-1 receptor agonist. The dual-mechanism approach builds on semaglutide while adding amylin activity to target weight management and metabolic control.
REIMAGINE 5 is a 68-week phase III study that compared CagriSema 1.0 mg/1.0 mg with Lilly’s once-weekly tirzepatide 5 mg in adults with T2D, with the dual primary endpoints assessed at week 60. REDEFINE 9 evaluated adults with overweight or obesity receiving CagriSema alongside a reduced-calorie diet and increased physical activity, comparing the treatment with placebo through week 68. The primary measures focused on changes in HbA1c and body weight in REIMAGINE 5 and relative weight change plus the proportion of participants achieving at least 5% weight loss in REDEFINE 9.
NVO’s CagriSema Data Readout Shows Strong Weight-Loss Gains
In REIMAGINE 5, CagriSema produced an estimated average body-weight reduction of 12.4% at week 60 compared with 9.1% for Lilly’s tirzepatide 5 mg. Novo reported that the difference met the study’s superiority criterion for weight loss. The result provides evidence on the potential efficacy of CagriSema at the 1.0 mg/1.0 mg dose against a 5-mg tirzepatide regimen in adults with T2D.
Year to date, NVO shares have lost 21.7% against the industry’s 12.4% growth.
Image Source: Zacks Investment Research
CagriSema also delivered a 1.71% reduction in HbA1c versus 1.67% for tirzepatide, meeting the prespecified criterion for non-inferiority. The finding indicates that CagriSema maintained broadly comparable glycemic efficacy while producing greater weight loss in this study population. CagriSema was also reported to be well tolerated overall, with a safety profile consistent with previous studies.
In REDEFINE 9, Novo’s CagriSema 1.0 mg/1.0 mg generated 21% weight loss at week 68 compared with 2% for placebo, meeting the primary superiority endpoint. The treatment also showed greater improvements than placebo on prespecified supportive measures, including systolic blood pressure, waist-to-height ratio and fasting lipid profile. Together, the two studies expand the CagriSema evidence base across both obesity and T2D and support further evaluation of the amylin-plus-GLP-1 combination.
The results also add another development avenue for Novo’s obesity and diabetes pipeline. The company is evaluating CagriSema across its REDEFINE program in obesity and REIMAGINE program in T2D, giving the candidate a broad late-stage development footprint. Novo clarified the weight-loss comparison should be viewed within the specific study design and doses studied rather than as a direct comparison with every approved tirzepatide regimen.
Novo filed a new drug application with the FDA in December 2025 seeking approval of CagriSema for weight management, with a regulatory decision expected in the fourth quarter of 2026. If approved, CagriSema would enter a competitive obesity market that includes Lilly’s Zepbound.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 15.6% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 73.8% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
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Novo's CagriSema Outshines Zepbound in Key Phase III Weight-Loss Study
Key Takeaways
Novo (NVO - Free Report) announced top-line results from two phase III studies evaluating once-weekly CagriSema, its investigational fixed-dose combination of cagrilintide and semaglutide, in obesity and type II diabetes (T2D). In the REIMAGINE 5 study, CagriSema 1.0 mg/1.0 mg delivered superior weight loss versus tirzepatide 5 mg while achieving a non-inferior reduction in HbA1c in adults with T2D. Tirzepatide is the active ingredient in Eli Lilly’s (LLY - Free Report) Zepbound and Mounjaro, which are marketed for chronic weight management and T2D, respectively. The findings add to the clinical evidence supporting CagriSema as Novo advances its next-generation obesity and diabetes portfolio.
The latest data are particularly relevant to the competitive incretin market, where Novo and Lilly are developing and commercializing therapies designed to produce meaningful weight loss alongside metabolic benefits. CagriSema combines two mechanisms in a single once-weekly treatment, pairing cagrilintide, a long-acting amylin receptor agonist, with semaglutide, a GLP-1 receptor agonist. The dual-mechanism approach builds on semaglutide while adding amylin activity to target weight management and metabolic control.
REIMAGINE 5 is a 68-week phase III study that compared CagriSema 1.0 mg/1.0 mg with Lilly’s once-weekly tirzepatide 5 mg in adults with T2D, with the dual primary endpoints assessed at week 60. REDEFINE 9 evaluated adults with overweight or obesity receiving CagriSema alongside a reduced-calorie diet and increased physical activity, comparing the treatment with placebo through week 68. The primary measures focused on changes in HbA1c and body weight in REIMAGINE 5 and relative weight change plus the proportion of participants achieving at least 5% weight loss in REDEFINE 9.
NVO’s CagriSema Data Readout Shows Strong Weight-Loss Gains
In REIMAGINE 5, CagriSema produced an estimated average body-weight reduction of 12.4% at week 60 compared with 9.1% for Lilly’s tirzepatide 5 mg. Novo reported that the difference met the study’s superiority criterion for weight loss. The result provides evidence on the potential efficacy of CagriSema at the 1.0 mg/1.0 mg dose against a 5-mg tirzepatide regimen in adults with T2D.
Year to date, NVO shares have lost 21.7% against the industry’s 12.4% growth.
Image Source: Zacks Investment Research
CagriSema also delivered a 1.71% reduction in HbA1c versus 1.67% for tirzepatide, meeting the prespecified criterion for non-inferiority. The finding indicates that CagriSema maintained broadly comparable glycemic efficacy while producing greater weight loss in this study population. CagriSema was also reported to be well tolerated overall, with a safety profile consistent with previous studies.
In REDEFINE 9, Novo’s CagriSema 1.0 mg/1.0 mg generated 21% weight loss at week 68 compared with 2% for placebo, meeting the primary superiority endpoint. The treatment also showed greater improvements than placebo on prespecified supportive measures, including systolic blood pressure, waist-to-height ratio and fasting lipid profile. Together, the two studies expand the CagriSema evidence base across both obesity and T2D and support further evaluation of the amylin-plus-GLP-1 combination.
The results also add another development avenue for Novo’s obesity and diabetes pipeline. The company is evaluating CagriSema across its REDEFINE program in obesity and REIMAGINE program in T2D, giving the candidate a broad late-stage development footprint. Novo clarified the weight-loss comparison should be viewed within the specific study design and doses studied rather than as a direct comparison with every approved tirzepatide regimen.
Novo filed a new drug application with the FDA in December 2025 seeking approval of CagriSema for weight management, with a regulatory decision expected in the fourth quarter of 2026. If approved, CagriSema would enter a competitive obesity market that includes Lilly’s Zepbound.
Novo Nordisk A/S Price and Consensus
Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote
NVO's Zacks Rank & Stocks to Consider
Novo currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , currently carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 15.6% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 73.8% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.