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Eli Lilly’s weight loss pill orforglipron clears its latest trial, paving way for approval
Eli Lilly Biotechnology Center is shown in San Diego, California, U.S. March 1, 2023.
Mike Blake | Reuters
Eli Lilly on Tuesday said its daily weight loss pill helped patients with obesity and Type 2 diabetes shed weight in a late-stage trial, meeting the study’s main goal and clearing the way for the company to file for approval of the drug globally.
The treatment is inching closer to becoming a new, needle-free alternative in the highly lucrative market for weight loss and diabetes drugs called GLP-1s. More convenient pills could boost supply for the treatments and make them easier to access than the pricey weekly injections currently dominating the space. The Eli Lilly pill also would not come with dietary restrictions, in contrast to a similar oral treatment from chief rival Novo Nordisk.
Eli Lilly shares climbed more than 4% Tuesday.
The highest dose of the pill, orforglipron, helped patients lose 10.5% of their weight, or 22.9 pounds, on average at 72 weeks, compared to 2.2% weight loss among those who took a placebo. The drug’s weight loss in the study was 9.6% when analyzing all patients regardless of discontinuations.
Eli Lilly’s pill met the trial’s other goals of helping patients lower their hemoglobin A1c, a measure of blood sugar levels. By the end of the study, most patients no longer met the criteria for Type 2 diabetes based on that metric. The rate of side effects and treatment discontinuations in the study, called ATTAIN-2, appeared to be generally consistent with two recent phase three trials on Eli Lilly’s drug.
Eli Lilly said it now has the full clinical trial data package required to file for approvals of the drug for chronic weight management with global regulators. The pharmaceutical giant expects to launch the pill around the world “this time next year,” CEO David Ricks told CNBC in early August.
In an interview, Eli Lilly’s Chief Scientific Officer Daniel Skovronsky, said the pill had “unprecedented efficacy” in patients with obesity and Type 2 diabetes, who typically have a more difficult time losing weight compared to those without diabetes. Skovronsky said he hopes that diabetes patients will be able to use the pill earlier in their disease to slow down its progression.
Existing GLP-1 injections have shown greater weight loss than Eli Lilly’s pill, but having an oral option that offers more than 10% for patients with both obesity and Type 2 diabetes is “actually very good, so that’s positive,” said Dr. Caroline Apovian, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital.
But she called it “concerning” that more patients – 10.6% of those on the highest dose – stopped taking the pill due to side effects compared with what has been seen in separate studies on the existing injections, Eli Lilly’s Zepbound and Novo Nordisk‘s Wegovy. Apovian said patients and their prescribers will have to weigh the risks and benefits of the pill and the injections when deciding which to take, including convenience, side effects and efficacy.
The side effects of Eli Lilly’s pill were mainly gastrointestinal, such as nausea and vomiting, and were mild to moderate in severity. An estimated 23.1% of those who took the highest dose experienced vomiting, while 36.4% and 27.4% had nausea and diarrhea, respectively.
Around 20% of patients stopped taking the pill for any reason, which is roughly the same rate as the placebo group. Skovronsky said that reflects a combination of reasons apart from side effects. Those can include patients who wanted to stop participating in a trial because they were able to access another obesity medication, or those who didn’t lose enough weight because they were taking a lower dose of the drug.
But he said most patients stay on the drug, and said “the most important thing here is the scale of the opportunity,” referring to the number of people around the world could benefit from orforglipron. More than 100 million adults in the U.S. alone have obesity, according to Centers for Disease Control and Prevention data.
Apovian said she’s most excited about an oral option entering the market not because of how much weight loss it can promote, but rather its potential to expand access to obesity treatments, especially since a pill is much easier to manufacture than an injection. Apovian hopes Eli Lilly’s pill will be priced lower than injections — which cost roughly $1,000 per month before insurance — and receive broader insurance coverage.
Tuesday’s results are the third set of late-stage data the company has released on orforglipron this year. In April, the pill succeeded in a shorter phase three trial on diabetes patients without obesity.
Earlier this month, the drug also met the goals of a separate study on patients with obesity and not diabetes, but fell short of Wall Street’s expectations. The pill’s weight loss was higher in that trial compared to Tuesday’s data, but “that’s expected,” given the differences in patient populations, said Dr. Jaime Almandoz, medical director of the Weight Wellness Program at UT Southwestern Medical Center.
Overall, some doctors have touted the pill’s weight loss in the trials, and some analysts say it will still be a viable competitor in the space due to factors such as its easier manufacturing and lack of dietary restrictions.
“The convenience and specifically the lack of fasting requirements and water restrictions with orforglipron is likely one of the main differentiators when people think about other oral agents with similar effectiveness for weight change and A1C levels,” said Almandoz.
He said a pill creates additional opportunities for individualized patient care “where there’s more autonomy.”
For example, some people may be hesitant to take injections for weight loss, said Dr. Andrew Krafston, clinical associate professor at the division of metabolism, endocrinology and diabetes at the University of Michigan
“While this is a surmountable barrier for many, oral therapy aligns with traditional medication treatment and may have higher acceptability,” he said, adding that pills are less likely to be in short supply.
Detailed trial data
The trial followed more than 1,600 people, who were randomized to receive three different target doses of Eli Lilly’s pill or a placebo. Patients started at a lower dose of the drug and gradually increased it at four-week intervals to reach their final target dose.
More than 50% of patients on the highest dose of Eli Lilly’s treatment lost at least 10% of their weight in the trial, while 28.4% of those participants lost at least 15%. Across the different groups, the company did not disclose how many patients lost at least 5% of their weight.
Orforglipron “may not be the answer” for patients who are morbidly overweight, said Howard Weintraub, clinical director of the Center for the Prevention of Cardiovascular Disease at NYU Langone Heart. But he said, “for a lot of people who need to lose a fair amount of weight, losing 10% can make a big diference.”
Orforglipron lowered A1C by an average of 1.3% to 1.8% across different doses at 72 weeks, from a starting level of 8.1%. Around 75% of participants taking the highest dose achieved an A1C of 6.5% or less, which is at or below what the American Diabetes Association defines as diabetes.
Eli Lilly’s pill also improved key cardiovascular risk factors.
“We now have study after study with GLP-1 agonists showing that they reduce very important outcomes, which is what I do every day as a preventive cardiologist,” Weintraub said. “I try my very best to prevent them from having heart attack, stroke and death.”
Eli Lilly’s pill works in a similar way to Wegovy, Ozempic and Novo Nordisk’s diabetes pill Rybelsus, targeting a gut hormone called GLP-1 to suppress a person’s appetite and regulate blood sugar. Novo Nordisk is also seeking approval of an oral version of Wegovy, which could come by year-end.
But unlike those three medications, Eli Lilly’s pill is not a peptide medication. That means it is absorbed more easily by the body and does not require dietary restrictions like Rybelsus or oral Wegovy does.
Business
Environment minister Bhupender Yadav heads to Brazil: India engages in pre-talks ahead of COP30; climate finance and adaptation on agenda – The Times of India
Union Environment Minister Bhupender Yadav is set to travel to Brasília on October 13-14 for a pre-COP meeting as India steps up preparations for the UN climate summit COP30, scheduled in Belém, Brazil, in November. The meeting aims to streamline negotiations on key issues and build consensus among ministers before the main conference. He confirmed his visit on his X account. The two-day pre-COP will bring together environment and climate ministers, senior negotiators, and observers to narrow differences on politically sensitive issues and build ministerial consensus ahead of the COP30 negotiations, PTI reported. The COP30 presidency expects 30-50 delegations and around 800 participants at the event.Pre-COPs, while not formal UNFCCC events, have become a routine instrument for host countries to focus ministerial attention on a limited set of political questions that otherwise take negotiators weeks to resolve. Ministers use these meetings to test negotiating texts, identify common ground, and prepare positions to expedite negotiations at the main COP.COP30 is unfolding against a complex geopolitical backdrop, with some developed countries reassessing climate strategies amid economic and energy security pressures. The United States’ withdrawal from the Paris Agreement has further heightened tensions. Disagreements over climate finance, the pace and responsibility of the energy transition, and burdens on developing countries remain sharp.Trust between developed and developing countries is fragile following COP29 in Baku, Azerbaijan, where many Global South delegates said finance outcomes fell short of expectations. Central issues include the scale and nature of climate finance, grant versus loan structures, and predictability of funds for adaptation and loss and damage. These topics are expected to dominate discussions in Brasília and later in Belém.Logistical concerns are adding further pressure. Reports indicate shortages of hotel rooms and high costs in Belém, potentially limiting participation of smaller delegations and vulnerable countries. Observers warn that unequal attendance could affect negotiating dynamics and the legitimacy of outcomes.Key discussion points include climate finance, the post-2025 collective finance goal, rules and integrity for international carbon trading under Article 6, adaptation and national adaptation plans, and translating the Global Stocktake into actionable timelines. Loss and damage finance will also be a priority, with ministers aiming to make it predictable and accessible.India has emphasised equity and differentiated responsibilities in climate action, urging developed countries to meet Article 9 obligations on finance. It has pressed for predictable and concessional support for adaptation and loss and damage, while highlighting the need for technology transfer and capacity building aligned with national circumstances. India has also underscored a just energy transition that allows space for development.Ahead of COP30, India plans to submit two key documents: an updated Nationally Determined Contribution (NDC), extending commitments to 2035, and the country’s first national adaptation plan (NAP). The updated NDC is expected to raise ambition on emissions intensity of GDP, non-fossil electricity capacity, and carbon sinks through forest and tree cover, without introducing new pledges. India has already exceeded its target for non-fossil installed capacity ahead of the 2030 deadline.Officials told PTI that India will closely monitor outcomes on carbon markets and accounting, ensuring that poorly designed rules do not shift burdens or create perverse incentives.
New Delhi: The intensity of foreign portfolio investor (FPI) selling in the Indian markets slowed down significantly in October, analysts said on Sunday.
The shift in the FPI trading strategy is significant and it stems from two factors.
One, the valuation differentials between India and other markets, which were high earlier, had come down significantly in recent weeks following the rally in other markets and consolidation in the Indian market.
“Two, the growth and earnings prospects for India have been revised upward by market experts. The GST cuts and the low interest regime are expected to boost India Inc’s earnings in FY27, which the market will soon start discounting,” said Dr VK Vijayakumar, Chief Investment Strategist, Geojit Investments Ltd.
Foreign investors turned buyers in the cash market on the last four trading sessions of the week ended on October 10.
The cash market buy figure during the last four trading sessions stands at Rs 3,289 crore.
The global market sentiment has again turned negative with the reignite of the US-China trade war, following US President Donald Trump’s threat to impose 100 per cent tariff on imports from China and restricting many critical US exports to China.
The FPI flows, going forward, will depend on how this renewed trade war pans out in the coming days, said analysts.
Siddhartha Khemka, Head of Research, Wealth Management, Motilal Oswal Financial Services Ltd, said Nifty50 edged higher by 104 points to close at 25,285 last Friday, amid improving global sentiment, supported by easing geopolitical tensions as Israel and Hamas agreed on the first stage of a ceasefire plan, along with signs of progress in a potential India–US trade deal.
“Renewed FPI buying also boosted sentiment. Additionally, India and the UK announced multiple collaborations across sectors including education, critical minerals, climate change, and defence,” he mentioned.
With the valuation differential coming down and Indian earnings likely to improve in FY27, foreign portfolio investors (FPIs) are likely to slow down selling going forward.
Sustained FPI selling continued in September with the sell figure through exchanges touching Rs 27,163 crore. However, in keeping with the long-term trend of buying through the primary market, they bought equity for Rs 3,278 crore in September.
On the macro front, investors will closely track India’s retail inflation print for September, to be released on Monday.
Business
Dalal Street rally! M-cap of eight of top-10 valued firms add Rs 1.94 lakh crore; TCS leads gain – The Times of India
Stock market: Dalal Street witnessed strong momentum last week as the combined market capitalisation of eight of India’s top 10 most-valued companies rose by Rs 1.94 lakh crore, reflecting renewed investor optimism.Tata Consultancy Services (TCS) emerged as the biggest gainer, while Hindustan Unilever and Life Insurance Corporation of India (LIC) saw declines in their valuations, PTI reported.The benchmark BSE Sensex rose 1,293.65 points, or 1.59%, last week, mirroring the overall positive momentum in equities.Among the top gainers, TCS’s market value surged by Rs 45,678.35 crore to Rs 10,95,701.62 crore, making it the biggest contributor to the weekly rally. Infosys followed with an increase of Rs 28,125.29 crore to Rs 6,29,080.22 crore, while HDFC Bank’s valuation climbed Rs 25,135.62 crore to Rs 15,07,025.19 crore.Bharti Airtel added Rs 25,089.27 crore to reach Rs 11,05,980.35 crore, and Reliance Industries gained Rs 25,035.08 crore, taking its market capitalisation to Rs 18,70,120.06 crore, maintaining its position as India’s most valuable company.Bajaj Finance rose by Rs 21,187.56 crore to Rs 6,36,995.74 crore, State Bank of India advanced by Rs 12,645.94 crore to Rs 8,12,986.64 crore, and ICICI Bank saw an increase of Rs 11,251.62 crore to Rs 9,86,367.47 crore.In contrast, mcap of LIC fell by Rs 4,648.88 crore to Rs 5,67,858.29 crore, and Hindustan Unilever’s declined by Rs 3,571.37 crore to Rs 5,94,235.13 crore.Reliance Industries retained the top spot among India’s most-valued firms, followed by HDFC Bank, Bharti Airtel, TCS, ICICI Bank, SBI, Bajaj Finance, Infosys, Hindustan Unilever, and LIC.
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