๐Ÿš€ Phase 3 ๐Ÿ† Record Phase 2 Results Roche / Genentech ยท Weekly injection

CT-388

GLP-1 / GIP Dual Agonist ยท Roche ยท Est. FDA: 2028-2029

CT-388 delivered 22.5% placebo-adjusted weight loss in Phase 2, the highest ever recorded in a controlled weight loss trial. 54% of participants reached a healthy BMI. Phase 3 ENITH1 and ENITH2 are now underway.

Phase 2: 22.5% placebo-adjusted weight loss, the highest ever recorded in a controlled trial. 54% of participants reached a healthy BMI. Phase 3 is now underway.

๐Ÿ’‰
Placebo-Adj. Loss
22.5%
Est. FDA
2028-29
At a Glance

CT-388 by the Numbers

Placebo-Adj. Weight Loss
22.5%
Highest ever in a controlled trial
Treatment-Regimen Loss
18.3%
At 48 weeks, still no plateau
Mechanism
GLP-1 + GIP
Dual agonist, weekly injection
Reached BMI Under 30
54%
More than half reached healthy BMI
Manufacturer
Roche / Genentech
Phase 3: ENITH1 + ENITH2
FDA Status
Phase 3
Est. FDA decision 2028-2029
Plain English

What Exactly Is CT-388?

A weekly dual agonist that produced the highest placebo-adjusted weight loss ever recorded in a trial. CT-388 is Roche and Genentech's entry into the GLP-1/GIP dual agonist class, and its Phase 2 results set a new benchmark.

CT-388 works similarly to Zepbound (tirzepatide), it's a dual agonist targeting both the GLP-1 and GIP receptors simultaneously. But the results in Phase 2 were markedly stronger than anything tirzepatide produced: a 22.5% placebo-adjusted weight loss and an 18.3% loss on the treatment regimen at 48 weeks, with no plateau observed.

To put 22.5% placebo-adjusted in context: that number strips out the effect of the diet and lifestyle program participants also followed, isolating only the drug's contribution. It's the highest drug-specific weight loss number ever measured in a controlled clinical trial. 54% of participants reached a BMI under 30, and 47.8% lost 20% or more of their body weight.

Phase 3 trials ENITH1 and ENITH2 started in Q1 2026. Roche and Genentech are moving fast, this is one of the most closely watched drugs in the obesity pipeline.

The Dual Mechanism

Two Hormones, One Drug

Targets GLP-1 and GIP simultaneously. Both reduce hunger, from different angles. CT-388 activates both GLP-1 and GIP receptors, producing synergistic appetite suppression and metabolic effects that go beyond either target alone.

๐Ÿง 
GLP-1 Receptor
Signals fullness to the brain and slows digestion. This is the same target as Wegovy and Ozempic. The GLP-1 component suppresses appetite by reducing hunger hormones and slowing gastric emptying, many patients describe the constant "food noise" going quiet.
โšก
GIP Receptor
Enhances the GLP-1 effect and improves how the body handles fat and glucose. Also activated by Zepbound (tirzepatide). The GIP component amplifies appetite suppression and improves insulin sensitivity, contributing to the superior results seen in dual versus single-target drugs.
1

Weekly Subcutaneous Injection

CT-388 is administered once a week as a small subcutaneous injection, similar to other GLP-1 class drugs. The dose is gradually escalated over several months to minimize gastrointestinal side effects during the adjustment period.

2

Rapid Appetite Suppression

GLP-1 and GIP receptor activation work together to dramatically reduce hunger. In Phase 2, 95.7% of participants lost at least 5% of their body weight, a remarkably consistent response across the trial population.

3

Sustained Loss, No Plateau

CT-388's Phase 2 results showed no weight loss plateau at 48 weeks. Like MariTide, the weight loss curve was still declining at the end of the observation period, suggesting peak effectiveness hasn't been reached yet at 48 weeks.

Phase 2 Clinical Trial Data

The Phase 2 Results

Phase 2 data announced January 2026: 22.5% placebo-adjusted, 18.3% treatment-regimen, no plateau at 48 weeks. Roche and Genentech announced Phase 2 results in January 2026. The data, including a 22.5% placebo-adjusted weight loss, set new records for the class and immediately positioned CT-388 as one of the most potent obesity drugs ever tested.

22.5%
Placebo-Adjusted Weight Loss
Highest ever in a controlled trial
18.3%
Treatment-Regimen Weight Loss
48 weeks, no plateau observed
54%
Participants Reached BMI Under 30
More than half achieved healthy BMI
๐Ÿ“Š Additional Phase 2 Highlights

47.8% of participants lost 20% or more of their body weight. 95.7% lost at least 5%. No weight loss plateau was observed at 48 weeks. To put 22.5% placebo-adjusted in context: Wegovy shows roughly 12% placebo-adjusted, and tirzepatide (Zepbound) shows around 17-18%. CT-388's 22.5% represents a meaningful step beyond the best currently approved drug.

โ„น๏ธ Phase 2 data was announced January 27, 2026. All participants received dietary counseling alongside the drug. Phase 3 ENITH1 and ENITH2 trials began enrolling in Q1 2026 and will provide definitive efficacy and safety data ahead of FDA submission.
Development Timeline

Where Things Stand

Phase 3 ENITH1 and ENITH2 are underway. FDA decision expected 2028-2029. After Phase 2 results in January 2026 that outperformed the field, Roche moved quickly into Phase 3. The full development roadmap below.

2021-2024
โœ“ Done
Phase 1, Safety confirmed
First-in-human studies confirmed CT-388 was safe and well-tolerated. Roche/Genentech determined optimal dosing ranges to take forward into Phase 2.
2024-Jan 2026
โœ“ Done
Phase 2 results
Results announced January 2026: 22.5% placebo-adjusted weight loss, the highest number ever recorded in a controlled weight loss trial. 54% reached BMI under 30. No plateau at 48 weeks.
Q1 2026, Now
โ— Happening Now
Phase 3 ENITH1 + ENITH2
Two large Phase 3 trials (ENITH1 and ENITH2) launched in Q1 2026. These trials will confirm Phase 2 results and provide the safety dataset needed for FDA review.
Est. 2027-2028
Up Next
NDA Filing
If Phase 3 results confirm Phase 2 findings, Roche submits a New Drug Application to the FDA requesting approval to market CT-388 in the US.
Est. 2028-2029
Up Next
FDA Decision
The FDA reviews Roche's data and decides. A 2028-2029 timeline is considered realistic if Phase 3 data holds up. If approved, CT-388 could become the most effective weight loss drug ever available.
๐Ÿ’ก Want to try it before approval?

Phase 3 ENITH trials are now enrolling. You would receive CT-388 at no cost under close medical supervision throughout the study.

Search Open Trials โ†’
Phase 2 highlights
Lost 5%+ of body weight 95.7%
Lost 20%+ of body weight 47.8%
Reached BMI under 30 54%
Phase 2 announced Jan 27, 2026

"Most of the pipeline drugs I see are incremental improvements. CT-388 is one of the few where the phase 2 data made me actually curious about what phase 3 is going to look like. That doesn't happen often."

Dr. Humberto Fernandez-Miro, MD

Dr. Humberto Fernandez-Miro, MD

Family Medicine ยท Clinical Research

Who Should Watch This

Is CT-388 Right for You?

Not available yet. Here's who it looks best suited for when it is. CT-388 isn't approved yet. Based on Phase 2 data and ongoing Phase 3 trials, here's who this drug looks most promising for, and what to weigh before deciding to wait for it.

โœ… Likely Good Candidates

  • Adults with BMI 30+ who want the highest-efficacy option available when it's approved
  • People who have tried Wegovy or Zepbound but haven't reached their goal weight
  • Anyone for whom reaching a "healthy BMI" (under 30) is the target, 54% in Phase 2 achieved it
  • People interested in the most potent dual agonist being developed today
  • Patients willing to wait until 2028-2029 for potentially the most effective oral drug ever approved

โš ๏ธ Things to Consider

  • Not FDA-approved, still at least 2-3 years away from potential approval
  • Phase 2 is typically smaller than Phase 3, results may shift in the larger trial population
  • Side effect profile is still being characterized at Phase 3 scale (12,000+ participants)
  • People who need treatment now should not wait, Wegovy and Zepbound are proven and available today
  • Pricing and insurance coverage are unknown until closer to approval
Head to Head

How CT-388 Stacks Up

CT-388 vs. current and upcoming weight loss drugs, by the numbers. CT-388's Phase 2 results outperformed everything else in the class on placebo-adjusted weight loss. A direct look at where it lands.

Drug Mechanism Best Weight Loss Dosing Status
๐Ÿ’‰CT-388 GLP-1 + GIP Dual Agonist 22.5% (placebo-adj.) / 18.3% Weekly Phase 3
๐Ÿ’‰Wegovy GLP-1 Agonist 15% Weekly FDA Approved
๐Ÿ’‰Zepbound GLP-1 + GIP Agonist 20-21% Weekly FDA Approved
๐Ÿ’‰Retatrutide GLP-1 + GIP + Glucagon 24.2% Weekly Phase 3
๐Ÿ’‰MariTide GIP Antagonist + GLP-1 16.2% (no plateau) Monthly Phase 3

CT-388's 22.5% is placebo-adjusted (drug effect isolated from lifestyle intervention). Retatrutide's 24.2% is the total treatment-regimen number. Direct comparisons between drugs are not available. All figures from published Phase 2/3 trial data.

Common Questions

CT-388 FAQ

These are different types of numbers. CT-388's 22.5% is placebo-adjusted, it represents only the drug's contribution, after subtracting weight lost by participants who received a placebo (who also followed a diet and lifestyle program). Retatrutide's 24.2% is the total treatment-regimen number, which includes the lifestyle component. CT-388's placebo-adjusted figure of 22.5% is the highest drug-specific effect ever measured in a weight loss trial. Comparing these numbers directly is tricky, they measure different things.
Yes, both are GLP-1/GIP dual agonists, they target the same two hormone receptors. However, the molecular structures and formulations differ between the two drugs. CT-388 is a Roche/Genentech compound with a distinct design from tirzepatide. Despite sharing the same mechanism class, CT-388's Phase 2 results were notably stronger than what tirzepatide showed at a comparable stage, suggesting the specific molecular properties matter significantly for efficacy.
A BMI of 30 is the threshold between "overweight" and "obese." For most people enrolled in obesity trials, starting BMI is well above 30, often in the 35-40 range. The fact that 54% crossed below that threshold means more than half of participants essentially reversed their obesity classification during the trial. This is clinically significant: treatments that restore a healthy BMI are associated with much greater reductions in cardiovascular risk, metabolic disease, and other obesity-related conditions.
Zepbound (tirzepatide) remains the best currently approved option, averaging 20-21% weight loss. CT-388's Phase 2 results were stronger, but it won't be available until 2028-2029 at the earliest. For someone who needs treatment today, Zepbound is an excellent choice, and by the time CT-388 might be approved, you could assess switching at that point if you haven't reached your goals. There's no reason to delay treatment waiting for CT-388.
Phase 2 data showed a side effect profile typical of the GLP-1/GIP class: nausea, diarrhea, vomiting, and constipation, predominantly during the dose-escalation period. These effects were generally mild to moderate and declined over time. 95.7% of participants completed the trial, a high completion rate suggesting the tolerability profile is manageable. The full safety picture will be established across thousands of participants in Phase 3.
Yes, Phase 3 ENITH1 and ENITH2 trials launched in Q1 2026 and are actively enrolling. Participants receive CT-388 at no cost with close medical supervision throughout the study. To find open trials near you, search for "CT-388" or "Roche obesity" on ClinicalTrials.gov.
Dr. Fernandez-Miro
Medically Reviewed by
Dr. Fernandez-Miro
Obesity Medicine