Roche's new obesity drug candidate wins nod for Phase III in KOR

Challenges Novo Nordisk and Eli Lilly

The Ministry of Food and Drug Safety (MFDS) approved 'Investigational New Drug (IND) for Roche's 'CT-388' on the 9th

Phase II trials demonstrated a weight reduction of 22.5% at 48 week

Global pharmaceutical giant Roche’s next-generation obesity drug candidate is finally entering the final hurdle of Phase III clinical trials in South Korea. As the drug is regarded as a competitive agent to Novo Nordisk and Eli Lilly, which currently dominate the market, the pharma-biotech industry is focusing heavily on initiating this large-scale trial targeting domestic patients.

On June 9, the Ministry of Food and Drug Safety (MFDS) officially approved an 'Investigational New Drug (IND) application filed by Roche Korea for a Phase III clinical trial evaluating the efficacy and safety of once-weekly RO7795068 (CT-388) in participants with obesity or overweight without type 2 diabetes.'  

Conducted as part of a global multicenter study, this trial aims to enroll 2,000 participants worldwide, with 144 participants allocated for South Korean patients with obesity. The clinical study commenced its local trial setup in February 2026 and is scheduled to run for approximately 2 years and 10 months until December 2028.

The newly cleared 'RO7795068' is a once-weekly subcutaneous dual GLP-1/GIP receptor agonist (development code name: CT-388), which Roche secured through its approximately $2.7 billion acquisition of US biotech firm Carmot Therapeutics in December 2023. It shares the same mechanism of action as Eli Lilly's mega-blockbuster obesity drug Zepbound (tirzepatide, Korean product name as Mounjaro).  

Roche's CT-388 previously shocked the market with its recently disclosed Phase II data. When a high dose (24 mg) was administered to obese patients over 48 weeks, it demonstrated a phenomenal mean weight reduction of 22.5% compared to the placebo group.  

These Phase II trial results had two disgtinguishing features. First, the 'weight loss plateau,' a common limitation observed with existing GLP-1 class therapeutics, was not observed even at 48-week, as the weight reduction curve maintained a continuous downward trajectory. Second, a staggering 47.8% of patients in the highest-dose cohort achieved a 20% or greater weight reduction, while roughly one in four (26.1%) demonstrated explosive efficacy, losing over 30% of their body weight. The drug also showed excellent results in resolving comorbidities, achieving a milestone. 73% of participants with prediabetes reverted to normal blood glucose levels.  

Currently, the global obesity market is dominated by Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, which has led to challenges in manufacturing and supply keeping up with demand.  

However, industry experts anticipate that the market landscape could shift rapidly following Roche's entry into Phase III testing. When compared with the clinical datasets of frontrunners Wegovy (approx. 15% weight loss) and Zepbound (approx. 20%), the '48-week 22.5% reduction without a plateau' demonstrated by Roche's CT-388 represents figures capable of establishing a clear competitive edge.  

Notably, Roche structurally engineered the molecule to minimize receptor desensitization, which occurs where drug receptor responses rapidly diminish, thereby maximizing the duration of efficacy. The company's strategic goal is to surpass existing standard-of-care medications in both ease of administration and tolerability.  

A biotech industry insider stated, "If the first round of competition of the obesity drug was centered on 'which product takes the market first,' the second round that has just commenced is a battle over 'which product can reduce body weight more completely without plateaus and side effects,'" and added, "Followingh Roche officially launching its global Phase III program, including South Korea, Roche's trial agent has emerged as the most promising next-generation contender with potential of breaking the current duopoly held by Lilly and Novo Nordisk."

Based on this MFDS approval, Roche Korea plans to collaborate closely with clinical trial sites, including major hospitals in South Korea, to accelerate patient recruitment and dosing. If the trial concludes successfully by the end of 2028 as scheduled, a three-way battle among Lilly, Novo, and Roche in the obesity market is projected to materialize as early as 2029.