From lowering sugar and weight loss to cardiovascular protection! Mounjaro completed the “Metabolic Transition”, and Lily.US (LLY.US) opens the second GLP-1 growth curve

The Zhitong Finance App learned that Eli Lilly (LLY.US), a leader in the US healthcare industry, is upgrading the blockbuster weight loss drug, Mounjaro, which has the title of “weight loss elixir” and has curative effects on reducing sugar, from being a comprehensive treatment platform covering cardiovascular and metabolic complications. The US Food and Drug Administration has now approved Mounjaro to reduce the risk of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke in adults with type 2 diabetes with heart disease, and further enhance its competitive advantage over the largest competitor Ozempic, a weight loss and hypoglycemic drug owned by Novo Nordisk.

Strong demand has driven Mounjaro's quarterly sales growth of 91% year over year to US$9.94 billion, and cardiovascular risk reduction indications not only expand the range of patients, but also help increase the willingness to pay insurance, further extending the market Eli Lilly faces from weight loss and sugar control to a larger cardiovascular and renal metabolic disease system.

What needs to be accurately distinguished is that Mounjaro in the US market is a diabetes brand, and Zepbound is an obesity brand with the same active ingredient tiverpotide; the approval for Mounjaro's cardiovascular indications this time does not mean that Zepbound has been approved for primary or secondary cardiovascular prevention. Both Mounjaro and Zepbound use tirzepatide (tirzepatide) as an active ingredient and have the same pharmacological mechanism. However, the former is mainly approved for type 2 diabetes and associated cardiovascular risk reduction (can also be used for weight loss in patients with high blood sugar), while the latter is mainly approved for long-term weight management and related indications in people who are obese or overweight for a long time.

Mounjaro Expansion Cardiovascular Indications

Eli Lilly's major diabetes and obesity treatment, Mounjaro, has been approved in the US and can be used to reduce the risk of serious cardiovascular problems, thereby further broadening the scope of application of the drug from controlling blood sugar and consolidating its position in the increasingly competitive glucagon-like peptide-1 drug (GLP-1) market.

Eli Lilly said in a statement on Friday that the US Food and Drug Administration (the US FDA) has approved Mounjaro to reduce cardiovascular risk in adults with type 2 diabetes and diagnosed heart disease.

Diabetic and obese patients are far more likely to develop cardiovascular disease than ordinary people. Therefore, the ability of drugs to prevent myocardial infarction, stroke, and cardiovascular death is an important indicator for measuring their value in addition to their hypoglycemic effects. Novo Nordisk's competitive diabetes injectable drug Ozempic has been approved for cardiovascular disease indications.

By the close of the US stock market on Thursday, Eli Lilly's stock price had accumulated a cumulative increase of about 9% since this year.

The FDA's major approval is based on a study involving more than 13,000 people. The study compared Mounjaro to Trulicity, a specific diabetes drug introduced earlier by Eli Lilly, and Trulicity has been shown to have cardioprotective effects. In this study, Mounjaro reduced the risk of myocardial infarction, stroke, and cardiovascular death, but its effectiveness was not significantly superior to that of this earlier drug.

Despite this, the drug still met the core research goal of proving that Mounjaro is at least as effective as Trulicity in protecting the heart. Patients taking Mounjaro saw a 16% reduction in all-cause deaths.

For Eli Lilly, the expanded indications add another weapon to one of the pharmaceutical industry's most valuable product portfolios. Mounjaro and its counterpart, the obesity drug Zepbound, have become a major growth engine for one of the world's largest pharma giants, headquartered in Indianapolis, and adding additional indications could help Eli Lilly cover more patients and provide a stronger basis for persuading insurance companies to cover these drugs.

Eli Lilly did not specifically test its obesity drug Zepbound to reduce the risk of cardiovascular disease. Instead, the company is studying whether the drug can reduce the risk of all-cause death in a large, multi-year trial. The relevant results are not expected to be announced until 2027.

The approval this time is Mounjaro's cardiovascular indication, which does not mean that Zepbound has been approved for primary or secondary cardiovascular prevention. Its underlying biology comes from glucose-dependent insulin-promoting peptides and glucagon-like peptide-1 receptor excitation: on the one hand, it promotes insulin release and inhibits inappropriate glucagon secretion in a glucose-dependent manner; on the other hand, it acts on central appetite and satiety pathways, delays gastric emptying, and improves adipose tissue and liver metabolism, thereby reducing blood sugar, body weight, visceral fat, blood pressure, and triglycerides, and reduces insulin resistance and systemic inflammation. Cardiovascular benefits are therefore not an “accidental by-product of weight loss,” but rather the result of simultaneous improvement of multiple metabolic risk pathways. However, whether there is a direct myocardial or vascular protective effect independent of weight loss still needs to be confirmed by more mechanistic studies.

The 100 billion dollar diet drug market enters the finals of efficacy expansion, production capacity and affordability

There is a high probability that Eli Mounjaro and Zepbound will continue to expand their indications in the future, mainly due to obesity, diabetes, obstructive sleep apnea, heart failure with conserved ejection fraction, chronic kidney disease, and metabolism-related fatty liver disease sharing pathological bases such as visceral fat, insulin resistance, chronic inflammation, and organ lipotoxicity; tirbotide has shown a 38% reduction in the risk of heart failure and a 56% reduction in the risk of hospitalization.

However, each new indication must rely on independent randomized trials to prove the hard end point benefits, and cannot be extrapolated from weight loss alone; Lilly is not currently conducting a specific Zepbound cardiovascular risk reduction test, but is evaluating whether it can reduce the risk of all-cause death in a large-scale multi-year study. The results are expected to be announced in 2027, so what will actually determine the indication landscape and valuation space in the future will be whether organ protection can cross the triple threshold of statistics, supervision, and insurance payments.

The mainstream institutional forecast range for the global pure diet pills market around 2030 is about US$95 billion to US$105 billion. If diabetes, cardiovascular and other metabolic indications are included, the broad market limit could be close to US$200 billion.

Goldman Sachs recently predicted that the global anti-obesity drug market will reach about US$95 billion by 2030; Morgan Stanley's benchmark scenario is US$105 billion, and the optimistic scenario is US$144 billion. If we start with sales of about US$6 billion in 2023, the benchmark scenario implies a compound growth rate of about 50.5% from 2023; J.P. Morgan predicts that the global pancreatic market, which includes diabetes and obesity indications, will reach 200 billion US dollars by 2030, with a wider range of estimates and statistics.