3 trial readouts that could shake up the obesity market this year

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The obesity market was a dominating force in 2024, with GLP-1 medications from Novo Nordisk and Eli Lilly becoming some of the best-selling drugs of the year. Their efficacy and widespread popularity have built a booming marketplace for weight loss therapies.

Analysts expect the space to reach a value of potentially hundreds of billions of dollars over the coming years. And with so much upside, new entrants are racing into the clinic to get a piece of the action. Small biotechs and Big Pharma alike are betting on both improved GLP-1s and novel approaches.

While only two companies currently have blockbuster obesity meds approved in the GLP-1 arena, more could be way soon. Here are some upcoming obesity trial readouts to watch in 2025.

Metsera

Drug: MET-097i

Anticipated data readout: Mid-2025

New York-based biotech Metsera has a pipeline of oral and injectable hormone-based drug candidates that aim to address “the limitations of current therapies.” Among the company’s three clinical-stage programs is MET-097i, an “ultra-long acting” injectable GLP-1 in phase 2b.

Over a 12-week phase 2a study, trial participants lost an average of more than 11% of body weight with individual patients losing as much as 20%, according to data released this week . While the study dosed patients weekly, Metsera is aiming to develop MET-097i into a monthly injection down the line. Gastrointestinal adverse events — a common complaint among users of GLP-1 drugs currently on the market — were mild or moderate and short-lived.

“These data strengthen our view of MET-097i as the potential first ultra-long acting GLP-1 [receptor agonist],” Dr. Steve Marso, chief medical officer of Metsera, said in a statement.

A monthly injectable could give Metsera a leg up on competitors with a more convenient weight loss regimen. Metsera is also chasing an oral GLP-1 alongside several other pharma companies looking for that edge in the market .

The biotech expects topline data from an ongoing phase 2b study of MET-097i in mid-2025. Metsera also anticipates “exploring” additional trials of the drug candidate in participants with obesity and Type 2 diabetes this year.

Skye Bioscience

Drug candidate: nimacimab

Anticipated data readout: Second quarter 2025

Sky Bioscience began a phase 2 trial last August for its cannabinoid receptor 1 inhibitor, nimacimab, as a weight loss therapy in obese patients. The drug candidate is a “first-in-class humanized monoclonal antibody” that blocks CB1 signaling, which can have anti-fibrotic, anti-inflammatory and metabolic actions, according to Skye. The study will not only explore weight loss, but also assess lean mass retention and gastrointestinal side effects.

The injection is being studied on its own and in combination with Wegovy, Novo Nordisk’s GLP-1 weight loss blockbuster.

“There is clearly a need for alternative mechanisms of action that can provide physicians and patients with improved overall health outcomes in the pursuit of weight loss beyond those achieved with GLP-1 and GIP drugs,” Punit Dhillon, Skye’s CEO, said last year.

Novo Nordisk is also exploring an oral cannabinoid receptor 1 inverse agonist, monlunabant, formerly INV-202. But the process has been rocky. The pharma giant picked up the drug when it acquired Inversago Pharmaceuticals in 2023, and a phase 2a study found that while all doses of monlunabant resulted in “ statistically significant weight loss compared to placebo,” there were some reported mild to moderate neuropsychiatric side effects,” including anxiety, irritability and sleep disturbances. Novo is planning to initiate a phase 2b trial in 2025.

Skye is also studying neuropsychiatric and cognitive effects in its study, expecting interim data from the trial in the second quarter of 2025 and final data by the end of year.

Eli Lilly

Drug candidate: orforglipron

Data release: Third quarter 2025

While Lilly is already a leader in the obesity market and taking on Novo in head-to-head trials of their GLP-1 injections, the pharma behemoth is also investigating an oral GLP-1 drug, orforglipron. Novo also has its own oral option in the works, as does Pfizer , Roche and more. In fact, Novo already has an approved oral GLP-1 on the market for diabetes patients, Rybelsus. However, Lilly is in late-stage testing for an obesity indication of its daily oral pill.

Lilly entered phase 3 testing for orforglipron in late 2024, and a large study of 1,500 participants is scheduled to wrap in August 2025 , with a readout likely soon after, according to Lilly’s third quarter earnings. An oral option may have several benefits for users, including a lower price as more options flood the market. Getting to market early among those chasing oral GLP-1 approvals would further solidify Lilly’s dominance in the booming space.

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