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Novo's CagriSema trial shows lower than expected weight

loss

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Only 57% on highest dose strength by end of trial

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Could be due to side effects or satisfactory weight loss

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Novo plans to start another trial in first half of 2025

By Maggie Fick, Jacob Gronholt-Pedersen and Mariam Sunny

LONDON/COPENHAGEN, Dec 20 (Reuters) - Novo Nordisk

shareholders were seeking on Friday to find out why such a high

number of patients in the late-stage trial of its

next-generation obesity drug candidate CagriSema did not reach

the highest dose strength of the medicine.

Disappointing data published by Novo from a late-stage trial

for the experimental drug wiped as much as $125 billion off the

Danish company's market value on Friday.

The lower-than-expected weight loss shown with CagriSema is

a blow to Novo's ambitions to find a successor to its Wegovy

weight-loss drug that is more powerful than competitor Zepbound,

also known as Mounjaro, made by Eli Lilly ( LLY ).

Novo said that if people adhered to treatment with

CagriSema, patients overall achieved weight loss of 22.7% after

68 weeks, with 40.4% losing 25% or more. That was lower than the

25% the company had expected.

Aside from the disappointing headline number, investors and

analysts focused on another puzzling data point: only 57% of

patients in the trial were on the highest dose-strength of the

medicine at the end of the 68 week trial.

CagriSema is a weekly injection combining semaglutide, which

is the active ingredient in its blockbuster drug Wegovy and

mimics the gut hormone GLP-1, with a separate molecule called

cagrilintide that mimics the pancreatic hormone amylin.

Investors and analysts noted that among the two other

patient groups in the trial, who were either given only

cagrilintide or semaglutide, much higher percentages reached the

highest dose: 83% for cagrilintide and 70% for semaglutide.

Novo did not give further details or respond to questions

about the lower number of patients reaching the highest dose.

The company will start a new trial in the first half of 2025.

But the reason may influence how the company designs the

next study.

Some investors and analysts said it could be a sign that

patients had suffered side-effects and had to limit their

intake.

It "clearly means tolerability was an issue", said Kevin

Gade, portfolio manager at Bahl & Gaynor. He owns shares in

Novo's top rival, Eli Lilly ( LLY ).

Alexander Jenke, a portfolio manager at Medical Strategy in

Munich, and a Novo shareholder, agreed. He said there may have

been higher rates of gastrointestinal adverse events such as

nausea, vomiting, and diarrhoea.

Nordea analyst Michael Novod had another theory: patients

may have stopped the injections after hitting a satisfactory

weight loss. The trial, investors noted, allowed patients to

stop at a lower dose if they wished.

"That's the thing that we can't answer today," Barclays

analyst Emily Field told Reuters. "Did Novo not meet the 25%

weight-loss bar because of the 'good guy' or the 'bad guy'?"

The "good guy", she said, would be patients who didn't get

to the highest dose in the trial because they were satisfied

with their weight loss, while the "bad guy" would be patients

whose side effects, like nausea, were so severe that they could

not increase their dose strength.