According to Zhitong Finance APP, the mid-term study data for Amgen's (AMGN.US) experimental weight loss drug MariTide is imminent, which will reveal comparisons between this drug and GLP-1 medications sold by Eli Lilly and Co (LLY.US) and Novo-Nordisk A/S (NVO.US). Analyst Salim Syed from Mizuhu stated in a recent report, "We see this stock as a double-edged sword, heavily reliant on MariTide data at the end of 2024."

Amgen's positive evaluation of its Phase II clinical trial over 52 weeks has driven the company's stock price up by 8% over the past year. In recent weeks, this momentum has waned as investors have sought more detailed information regarding the safety of this injectable medication.

Amgen stated that compared to weekly GLP-1 treatments like Wegovy from Novo-Nordisk and Zepbound from Eli Lilly and Co, this drug can achieve faster weight loss, maintain weight better, and require fewer injections. Chief Scientific Officer Jay Bradner mentioned during a recent conference call, "MariTide has the potential to become the first treatment in this category with monthly or even less frequent dosing."

Wall Street analysts expect that the multi-dose trial will show weight loss of at least 20% and emphasize the need to elaborate on potential side effects, including nausea, bone density issues, heart rate, and blood sugar.

Wegovy was approved for the treatment of obesity in 2021 after studies indicated a 15% weight loss over 68 weeks, while Zepbound data showed over 22% weight loss within 72 weeks.

Analyst Matt Phipps from William Blair & Co stated, "Achieving a weight loss of over 20% is the minimum benchmark for MariTide, but many investors expect weight reduction closer to 25%." He added that the trial needs to prove that weight loss is related to dosage.

Amgen plans to announce the results of the second phase trial by the end of the year and has outlined the third phase trial plan required for submitting the drug for regulatory approval.

MariTide may eventually enter a weight loss drug market projected by some analysts to exceed $150 billion annually. A small phase one trial showed that patients receiving the highest dose, injected once a month for three months, lost 16% of their weight.

However, morningstar analyst Karen Anderson stated that the drug is associated with nausea and vomiting, which "caused half of the patients to drop out of the trial."

She said, "The second phase provided Amgen an opportunity to refine the dosage size and the rate at which patients increase the dosage, to maximize weight loss and reduce side effects. I expect the weight loss to be significant, possibly much higher than the 18% level we saw for Eli Lilly and Co's Zepbound at 48 weeks."

Phipps stated that if Amgen does not provide information regarding the rates and severity of nausea, "it will be viewed negatively." Wegovy causes nausea in over 40% of patients, while the proportion for Zepbound is about 25%.

Different approaches

Wegovy acts on the receptors of the hormone GLP-1 (glucagon-like peptide-1) that regulates appetite and lowers blood sugar. Zepbound stimulates both GLP-1 and another gut hormone called GIP (gastric inhibitory peptide).

Amgen has taken a different approach. MariTide is an antibody that binds to a pair of peptide chains, a structure capable of activating the GLP-1 receptor while blocking the GIP receptor.

On Wednesday, Amgen's stock closed at $287.87, down about 9% from earlier this month, when analysts at Cantor Fitzgerald indicated that their assessment of the Phase 1 MariTide data showed a decline in bone density, which could increase the risk of fractures.

Some studies suggest that GIP assists in bone formation; therefore, as mentioned in the Cantor report, Amgen's strategy to suppress this hormone theoretically raises concerns about bone loss.

Amgen issued a statement saying, 'No connection has been observed between taking MariTide and changes in bone density.' The company previously explained that MariTide was developed based on genetic data indicating that GIP suppression can prevent obesity.

Jefferies analyst Michael Yee stated that if the Phase 2 trial shows a weight loss of 23% to 25% or more, a patient dropout rate of less than 10%, and includes quarterly dosing, then Amgen's stock could rise by 20%.

He said at the end of October that if the weight loss is less than 20%, and safety issues or high rates of nausea and vomiting lead to a dropout rate exceeding 15%, then the stock price could drop by 20%.