Phase 2 Clinical Trial • NEJM 2023

Retatrutide: What the Research Actually Shows

Last updated: March 25, 2026

Retatrutide (LY3437943) produced an average 24.2% body weight loss at 48 weeks in the landmark Phase 2 trial published in the New England Journal of Medicine — the highest weight loss recorded for any anti-obesity drug in a clinical trial to date. It works by simultaneously activating three metabolic receptors: GLP-1, GIP, and glucagon.

0%
Maximum Weight Loss
(12mg, 48 weeks)
0
Trial Participants
0
Receptor Targets
(GIP + GLP-1 + Glucagon)

A Triple Receptor Agonist

Retatrutide (LY3437943) simultaneously activates three metabolic receptors — a combination no approved drug achieves. Here's what each target does.

🔵

GLP-1 Receptor

Controls appetite, slows gastric emptying, and enhances insulin secretion in response to meals. This is the same target as semaglutide (Ozempic/Wegovy) — a proven weight-loss mechanism in hundreds of thousands of patients.

🟢

GIP Receptor

Boosts insulin sensitivity and enhances fat metabolism. This is the same second target added by tirzepatide (Mounjaro/Zepbound), which is responsible for its superior efficacy over earlier GLP-1-only drugs.

★ Breakthrough Target 🟣

Glucagon Receptor

The breakthrough third target. Activating glucagon receptors increases energy expenditure, promotes direct fat burning, and enhances hepatic (liver) metabolism. Only retatrutide hits this target — and it may explain the superior weight loss numbers.

Weight Loss by Dose

Average percent body weight lost across all dose groups, measured at 24 and 48 weeks. Bars animate when you scroll to this section.

24-Week Results
Placebo −1.6%
1mg dose −7.2%
4mg dose −12.9%
8mg dose −17.3%
12mg dose −17.5%
48-Week Results
Placebo −2.1%
1mg dose −8.7%
4mg dose 16.3% avg across dose groups
−17.1%
8mg dose −22.8%
12mg dose ★ Maximum
−24.2%

Who Actually Loses Weight?

Percentage of participants achieving meaningful weight loss thresholds at 48 weeks. The higher the dose, the more consistent the results.

12mg — Peak Dose
100%
≥5% weight loss
93%
≥10% weight loss
83%
≥15% weight loss
8mg Dose
100%
≥5% weight loss
91%
≥10% weight loss
75%
≥15% weight loss
4mg Dose
92%
≥5% weight loss
75%
≥10% weight loss
60%
≥15% weight loss
Placebo
27%
≥5% weight loss
9%
≥10% weight loss
2%
≥15% weight loss

How Does It Compare?

Retatrutide vs the two leading approved GLP-1 medications. These are cross-trial estimates — see the note below.

Tirzepatide
Mounjaro / Zepbound • Eli Lilly
Mechanism Dual agonist
(GIP + GLP-1)
Max Weight Loss ~22.5%
(72 weeks, SURMOUNT-1)
FDA Status ✓ Approved (Zepbound)
Injection Weekly ✓
Availability Available now
Semaglutide
Ozempic / Wegovy • Novo Nordisk
Mechanism Single agonist
(GLP-1 only)
Max Weight Loss ~14.9%
(68 weeks, STEP 1)
FDA Status ✓ Approved (Wegovy)
Injection Weekly ✓
Availability Available now
⚠️
Important caveat: These are cross-trial comparisons, not head-to-head. Different study designs, patient populations, dose escalation protocols, and trial durations make direct comparison inherently imprecise. Retatrutide's Phase 2 data cannot be directly compared to Phase 3 trials of approved medications.

Side Effects Breakdown

Reported adverse events for the 12mg dose group. Rates are consistent with the broader GLP-1 drug class — mostly GI-related and dose-dependent.

Nausea 24%
Mild to moderate, dose-related. Most common during titration.
Diarrhea 22%
Mild to moderate, typically transient.
Vomiting 13%
Dose-related, usually during escalation phase.
Constipation 12%
Decreased Appetite 9%
★ This is the mechanism working as intended
Heartburn / Dyspepsia 9%

💡 Titration Matters

Starting at 2mg and slowly titrating up to higher doses significantly reduced GI side effects compared to starting directly at 4mg. Slow escalation is the standard protocol in clinical practice for all GLP-1-class drugs.

📊 Context on These Numbers

Most GI side effects were mild to moderate in severity and resolved over time. The discontinuation rate due to adverse events was low and consistent with other drugs in this class. No new serious safety signals were identified in the 48-week trial period.

⚗️ 12mg Dose Data

All side effect percentages shown here are for the highest-dose group (12mg) where GI effects are most pronounced. Lower doses (4mg, 8mg) showed meaningfully lower rates of nausea and vomiting while still delivering strong efficacy.

Trial Details

All data on this page is sourced from the Phase 2 NEJM publication. Full citation below.

Phase 2 Randomized Controlled Trial

Retatrutide (LY3437943) for Obesity — Full Study Record

Trial ID NCT04881760
Published New England Journal of Medicine, August 10, 2023
Authors Jastreboff AM, Kaplan LM, Frías JP, Wu Q, Du Y, Gurbuz S, Coskun T, Haupt A, Milicevic Z, Hartman ML, et al.
Funded By Eli Lilly and Company
Duration 48 weeks of treatment
Participants 338 adults (51.8% men)
Population Adults with BMI ≥30, or BMI 27–29.9 with at least one weight-related condition (e.g., hypertension, dyslipidemia, obstructive sleep apnea)
Design Phase 2, randomized, double-blind, placebo-controlled, dose-ranging study
Primary Endpoint Percent change in body weight from baseline to 24 weeks

Phase 3 Data: The Numbers Get Even Better

The Phase 2 NEJM data was already historic. Then Phase 3 reported — and retatrutide may be setting records that won't be broken for a long time.

⚖️ Phase 3 Weight Loss Data (Dec 2025)

23.7%
All participants
28.7%
Completers only

Placebo-adjusted weight loss hit 26.6%. The trial enrolled people with obesity plus knee osteoarthritis — a harder-to-treat population than the typical obesity trial. These may be the highest weight-loss numbers ever reported in a late-stage pharmaceutical trial for any indication.

🦵 Bonus Finding: Knee Pain −75%

The Phase 3 trial specifically enrolled patients with both obesity and knee osteoarthritis. In addition to exceptional weight loss, participants reported a 75% reduction in knee pain — a result driven both by reduced joint loading and direct anti-inflammatory effects.

This positions retatrutide as potentially relevant well beyond obesity — it could become a treatment of choice for the large overlap population with obesity-driven osteoarthritis.

🫀 Phase 2 Liver Substudy: Cardiometabolic Profile

A liver-focused substudy within the Phase 2 program examined retatrutide's effects on liver fat and cardiometabolic markers. The glucagon component is believed to drive direct hepatic fat oxidation — and the results reflect this.

81–82%
Liver fat reduction
(higher doses)
−35–40%
Triglycerides
reduced
−12–22%
LDL reduction
range

Placebo comparison for liver fat: the placebo group saw a 0.3% increase in liver fat over the same period — making the contrast even more striking.

Who Researches Retatrutide?

This Research Is Commonly Explored By People Who...

  • Are interested in the next generation of multi-receptor agonists (GLP-1/GIP/glucagon triple agonist)
  • Want to understand Phase 2 data showing up to 24% weight loss at 48 weeks
  • Have followed GLP-1 research and want to track emerging therapies in the pipeline
  • Are curious about glucagon receptor activation and its role in energy expenditure
  • Want to compare retatrutide's early data against approved options like semaglutide and tirzepatide

This Research May Not Be Relevant If...

  • You want something available now — retatrutide is still in Phase 3 clinical trials (not FDA approved)
  • You prefer established safety profiles — long-term data is still being collected
  • You need a treatment plan today — discuss approved options with your healthcare provider first
📚

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⚕️ Disclaimer: This is educational content, not medical advice. Always consult a healthcare provider before making decisions about your health.

What the Data Actually Tells Us

Separating confirmed Phase 2 findings from what still needs to be established in Phase 3 trials.

What We Know
  • Retatrutide achieved the highest average weight loss of any obesity medication tested in a clinical trial
  • 100% of participants on 8mg and 12mg doses lost at least 5% of body weight — a clinically meaningful threshold
  • The triple agonist mechanism (adding glucagon receptor activation) appears to offer genuinely superior results compared to dual-agonist drugs
  • Side effects are manageable and mostly GI-related, consistent with the broader drug class — slow titration reduces incidence
  • Weight loss continued to increase from 24 to 48 weeks, suggesting the drug had not yet hit a plateau at study end
⚠️ What We Don't Know Yet
  • Phase 3 trials are ongoing — larger scale data across more diverse populations is still needed before FDA review
  • Long-term safety beyond 48 weeks has not yet been established in published data
  • No published head-to-head trials against tirzepatide or semaglutide exist — cross-trial comparisons have real limitations
  • FDA approval timeline remains uncertain; current estimates suggest 2026–2027 at the earliest pending Phase 3 readouts
  • Real-world effectiveness may differ from the highly controlled clinical trial setting (adherence, diet, comorbidities)

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What to Expect: A Patient Timeline

Based on the retatrutide Phase 2 trial (NEJM 2023, NCT04881760, n=338) at the highest dose (12 mg/week). Lower doses produce proportionally smaller effects. Individual results vary significantly.

Week 1–2

Triple Receptor Activation & Rapid Appetite Suppression

GIP + GLP-1 + Glucagon Common: Nausea Dose: 2 mg/wk start

Retatrutide simultaneously activates GIP, GLP-1, and glucagon receptors — a triple mechanism that distinguishes it from semaglutide (GLP-1 only) and tirzepatide (GIP + GLP-1). GLP-1 activity suppresses appetite, GIP enhances the GLP-1 response, and glucagon receptor activation increases energy expenditure and thermogenesis. Phase 2 participants experienced strong early satiety signals within days. Nausea and GI discomfort are common early on due to accelerated dose escalation in the trial protocol.

Month 1

Rapid Early Weight Loss

~3–7% early loss Energy expenditure ↑ Food intake ↓↓

The glucagon receptor component of retatrutide drives higher energy expenditure compared to GLP-1-only drugs — participants burn more calories even at rest. Phase 2 data shows early weight loss trajectories steeper than observed with semaglutide or tirzepatide at equivalent timepoints. Food intake reduction is profound, with many participants describing dramatic changes in hunger and portion size within the first month.

Month 3

Significant Weight Loss & Metabolic Changes

~12–17% loss by wk 24 Insulin sensitivity ↑ Triglycerides ↓

By week 12–24, retatrutide participants in the Phase 2 trial showed approximately 12–17% body weight loss (12 mg group), outpacing semaglutide at the same timepoints. Fasting insulin, triglycerides, and waist circumference all improve significantly. Lean mass preservation is a key differentiator — glucagon receptor agonism promotes fat oxidation while sparing muscle. GI side effects become less frequent as the dose stabilizes.

Month 6+

Record-Setting Weight Loss & Body Composition Changes

Up to 24.2% at 48 wks Body composition ↑ Visceral fat ↓↓

The Phase 2 trial showed 24.2% average body weight loss at 48 weeks in the highest-dose group (12 mg) — a result unprecedented in clinical trials for a pharmacological agent at that time. All dose groups showed statistically significant improvements in waist circumference, systolic blood pressure, fasting glucose, and lipid panels. Visceral (abdominal) fat — the metabolically dangerous type — showed particularly strong reductions. Phase 3 trials (TRIUMPH program) are ongoing to confirm these results in larger populations.

Disclaimer: This page is for educational and informational purposes only. It is not medical advice. Retatrutide is an investigational drug not yet approved by the FDA for any indication. Always consult with a qualified healthcare provider before starting any medication or treatment protocol. Data sourced from published peer-reviewed research (NEJM 2023, NCT04881760).