Novo Nordisk Faces Investor Concerns Over Hybrid CagriSema Trial Results For Weight Loss

In December, Novo Nordisk A/S NVO released headline results from the REDEFINE 1 Phase 3 trial in the global REDEFINE program.

When evaluating the effects of treatment if all people adhered to treatment, people treated with CagriSema achieved a weight loss of 22.7% after 68 weeks compared to a reduction of 11.8% with cagrilintide 2.4 mg, 16.1% with semaglutide 2.4 mg and 2.3% with placebo alone.

Also Read: Novo Nordisk's Higher Dose Of Wegovy Shows Roughly 21% Weight Loss

In interviews with Reuters, some investors, analysts, and trial participants have raised concerns over CagriSema's side effects, dosing protocol, and effectiveness compared to Eli Lilly And Co's LLY Zepbound (Mounjaro).

Five patients from the REDEFINE-1 and REDEFINE-4 trials interviewed by Reuters said CagriSema helped them lose weight rapidly, but side effects, such as nausea, constipation, and fatigue, were significant.

The weaker-than-expected trial data has raised doubts about Novo Nordisk's ability to compete with Eli Lilly's weight-loss drug.

In November, Novo Nordisk said its hybrid drug, CagriSema, aims to reduce weight by 25% without added side effects.

A key issue emerging from the trial is that only 57.3% of patients reached the highest dose of CagriSema. Novo has not clarified whether this was due to intolerable side effects or effective weight loss at lower doses.

Investors and analysts were also surprised by the study's flexible dosing protocol, which allowed participants to adjust their dosage instead of following a strict schedule.

Some believe this contributed to the low uptake of the highest dose and may have affected overall trial results.

Novo Nordisk will release its fourth quarter 2024 earnings on Wednesday. Analysts expect sales of DKK 79.73 billion and EPS of DKK 5.86 as per data from Benzinga Pro.

Reuters, citing a Barclays analyst, noted that the lack of clarity has fueled negative sentiment, with concerns that CagriSema may be less effective than Eli Lilly's Zepbound, have worse tolerability, and be more difficult to manufacture.

Last week, Novo Nordisk released topline results from a phase 1b/2a trial with amycretin intended for once-weekly subcutaneous administration.

When evaluating the effects of treatment if all people adhered to treatment from a mean baseline body weight of 92.7 kg, people treated with amycretin achieved an estimated body weight loss of 9.7% on 1.25mg (20 weeks), 16.2% on 5mg (28 weeks) and 22.0% on 20mg (36 weeks).

Price Action: At last check on Tuesday, NVO stock was down 0.94% to $81.87 during the premarket session.

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