Novo Nordisk NVO has achieved the primary endpoint in the second late-stage study evaluating its next-gen subcutaneous obesity treatment candidate, CagriSema, in patients with obesity and type 2 diabetes (T2D) and a mean baseline body weight of 102 kg. The results showed that treatment with the candidate led to a statistically significant and superior weight loss at week 68 compared with placebo.

NVO’s CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and Wegovy. The two molecules promote weight loss by suppressing hunger, enhancing feelings of fullness and helping individuals consume fewer calories.

The phase III REDEFINE 2 study followed a flexible protocol, enabling patients to adjust their dosing throughout the study. After 68 weeks, 61.9% of those treated with CagriSema reached the highest dose.

NVO’s Phase III REDEFINE 2 Study Results in Detail

Analysis of the study data after 68 weeks, assuming all people adhered to treatment, revealed that a superior weight loss of 15.7% was achieved with CagriSema compared with a reduction of 3.1% with placebo. The study also met its co-primary endpoint of 5% weight loss or more after 68 weeks in 89.7% of patients on CagriSema compared with 30.3% by placebo.

Despite the positive results, Novo Nordisk’s shares tumbled 9.4% on Monday as the 15.7% weight loss observed in obese and T2D patients treated with CagriSema in the phase III REDEFINE 2 study, failed to meet its guidance for 25% weight loss at week 68, which was provided on the third-quarter earnings call.

We remind the investors that NVO faced a major setback in December 2024, after the 22.7% weight loss observed in obese patients treated with CagriSema in the phase III REDEFINE 1 study, which also failed to meet the company’s guidance for 25% weight loss at week 68.

In the past three months, shares of Novo Nordisk have lost 27.3% against the industry’s 6.3% growth.

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Additionally, analysis of the study data regardless of treatment adherence showed that obese and T2D patients treated with CagriSema achieved a superior weight loss of 13.7% compared with 3.4% with placebo. In the REDEFINE 2 study, CagriSema was overall well-tolerated and demonstrated an acceptable safety profile. Adverse events related to treatment with CagriSema were mostly gastrointestinal, which were mild to moderate in severity.

Novo Nordisk is currently evaluating the weight loss candidate, CagriSema, in four ongoing phase III studies under the REDEFINE Program, including the phase III REDEFINE 1 and REDEFINE 2 studies. Per management, the REDEFINE 2 study results confirmed the superior efficacy of CagriSema in people with overweight or obesity and T2D.

Novo Nordisk plans to submit a regulatory application seeking the first approval for CagriSema for the obesity indication in the first quarter of 2026. Detailed findings from REDEFINE 1 and REDEFINE 2 studies will be shared at a later medical conference.

Please note that on the fourth-quarter earnings conference call, NVO announced that it is gearing up to initiate yet another phase III study, REDEFINE 11, in the first half of 2025 to further evaluate CagriSema’s potential in obesity treatment. This planned study will have a longer duration and focus on dose escalation and re-escalation.

Novo Nordisk A/S Price and Consensus

Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote

NVO’s Zacks Rank and Stocks to Consider

Novo Nordisk currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the sector are Gilead Sciences GILD, BioMarin Pharmaceutical BMRN and Corcept Therapeutics CORT, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 30 days, Gilead Sciences’ earnings estimate for 2025 has improved from $7.60 to $7.87 per share. During the same timeframe, the estimate for earnings per share for 2026 has improved from $7.93 to $8.27. In the past three months, shares of Gilead Sciences have gained 26.9%.

GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.

In the past 30 days, the estimate for BioMarin Pharmaceutical’s 2025 earnings per share has increased from $4 to $4.25. the estimate for 2026 earnings per share has increased from $5.16 to $5.29 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have gained 8.7%.

BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 32.36%.

In the past 30 days, the estimate for Corcept Therapeutics’ 2025 earnings per share has increased from $1.66 to $1.84. The estimate for 2026 earnings per share has increased from $2.86 to $3.05. In the past three months, shares of Corcept Therapeutics have gained 0.1%.

CORT’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 20.08%.

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