CLINICAL TRIALS PROFILE FOR MOUNJARO

All Clinical Trials for MOUNJARO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05708859 ↗	Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT	Not yet recruiting	Eli Lilly and Company	Phase 4	2023-02-01	A multi-center, randomized, double-blind, placebo-controlled, parallel-group phase IV Study evaluating the effects of tirzepatide on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of type II Diabetes (T2DM) and atherosclerosis.
NCT05708859 ↗	Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT	Not yet recruiting	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Phase 4	2023-02-01	A multi-center, randomized, double-blind, placebo-controlled, parallel-group phase IV Study evaluating the effects of tirzepatide on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of type II Diabetes (T2DM) and atherosclerosis.
NCT06073184 ↗	Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium	Not yet recruiting	University Health Network, Toronto	Phase 2	2024-09-01	The incidence of endometrial cancer is increasing at an alarming rate. This trend parallels the rising rate of obesity, the most significant risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility are treated with progestin therapy, such as progestin intra-uterine device (pIUD), which is associated with a mediocre response rate and high recurrence rate, and does not address the underlying cause, obesity. Therefore, the investigators want to assess whether the addition of a weight-loss drug to pIUD will improve their oncologic, reproductive and metabolic outcomes.
NCT06162715 ↗	GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Feasibility Trial	Not yet recruiting	Vanderbilt University Medical Center	Phase 2	2024-10-01	The goal of this pilot clinical trial is to determine the effectiveness of Tirzepatide in patients with persistent obesity (BMI > 30) 12 months after bariatric surgery (Roux-en-Y Gastric Bypass). The investigators also aim to determine the frequency of side effects with Tirzepatide in this patient population. Patients who take tirzepatide 12 months after bariatric surgery will be compared to patients who receive a placebo.
NCT06734273 ↗	Randomized Control Trial of Sleeve Gastrectomy with Tirzepatide in Maximizing Weight Loss	RECRUITING	Nicholas Skertich	EARLY_PHASE1	2025-03-10	This study examines whether adding tirzepatide-a medication that helps with weight loss-after sleeve gastrectomy surgery can help people lose more weight after the surgery; better improve conditions like Type 2 diabetes, high blood pressure, high cholesterol, and sleep apnea after surgery and; whether this causes more complications or side effects compared to surgery alone.
NCT07179120 ↗	Can Fat-Burning Shots Boost Fertility? Comparing Weight-Loss Injections vs. Healthy Habits for Obese Men With Low Sperm Health	NOT_YET_RECRUITING	First Affiliated Hospital of Wenzhou Medical University	PHASE2	2026-05-01	Why is this study being done? Obesity can harm men's fertility by lowering sperm quality and hormone levels, making it harder to have children. Weight loss through diet and exercise helps, but it's often hard to stick with. New medicines called GLP-1 receptor agonists, like semaglutide (Ozempic) and tirzepatide (Mounjaro), help people lose weight and improve health. Early studies suggest these drugs might also boost sperm health in obese men, but more proof is needed. This study tests if these drugs can safely improve fertility in obese men who are having trouble conceiving. What will happen in this study? This is a 48-week study at several hospitals in China. About 180 men will be randomly assigned to one of three groups: Group 1: Standard lifestyle changes, like a healthy diet and exercise, guided by experts. Group 2: Weekly injections of semaglutide, starting low and increasing as tolerated. Group 3: Weekly injections of tirzepatide, starting low and increasing as tolerated. All men will have regular check-ups, including blood tests, semen analysis, and weight measurements. We will track sperm quality, hormone levels, weight loss, and whether their partners get pregnant naturally. The study includes an 8-week adjustment period, 24 weeks of treatment, and 16 weeks of follow-up. Who can join this study? Men aged 20-45 who are married, obese (BMI 28 or higher or waist size 90 cm or more), and have been trying to have a baby for at least a year without success due to low sperm count or poor sperm movement. Their female partners must be under 40 and have no major fertility issues. Men must be willing to attend visits and provide samples. People with serious health problems, recent use of similar drugs, or other causes of infertility (like genetic issues) cannot join. How long will this study last? The full study lasts 48 weeks (about 11 months), with visits every 4-8 weeks, plus monthly phone check-ins for pregnancy updates. What are the possible benefits and risks? Benefits: If the drugs work, men may lose weight, improve sperm quality, and have a better chance of their partners getting pregnant naturally. They might also feel healthier overall. Risks: Common side effects include nausea, vomiting, or diarrhea from the drugs, which usually improve over time. Rare risks include pancreas inflammation or gallbladder issues. Lifestyle changes might cause minor injuries from exercise. All side effects will be monitored closely, and participants can quit anytime. Insurance covers any study-related harm.

Clinical Trial Conditions for MOUNJARO

Condition Name

Condition Name for MOUNJARO
Intervention	Trials
Atherosclerosis	1
Atypical Hyperplasia	1
Endometrial Cancer	1
Obesity and Obesity-related Medical Conditions	1

Condition MeSH

Condition MeSH for MOUNJARO
Intervention	Trials
Obesity	2
Weight Loss	1
Hyperplasia	1
Endometrial Neoplasms	1

Clinical Trial Locations for MOUNJARO

Trials by Country

Trials by Country for MOUNJARO
Location	Trials
United States	3

Trials by US State

Trials by US State for MOUNJARO
Location	Trials
Illinois	1
Tennessee	1
California	1

Clinical Trial Progress for MOUNJARO

Clinical Trial Phase

Clinical Trial Phase for MOUNJARO
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for MOUNJARO
Clinical Trial Phase	Trials
Not yet recruiting	3
NOT_YET_RECRUITING	1
RECRUITING	1

Clinical Trial Sponsors for MOUNJARO

Sponsor Name

Sponsor Name for MOUNJARO
Sponsor	Trials
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	1
University Health Network, Toronto	1
Vanderbilt University Medical Center	1

Sponsor Type

Sponsor Type for MOUNJARO
Sponsor	Trials
Other	5
Industry	1

Clinical Trials Update, Market Analysis, and Projection for MOUNJARO (Tirzepatide)

Last updated: December 2, 2025

Summary

Mounjaro (tirzepatide), developed by Eli Lilly and Company, is a novel dual GIP and GLP-1 receptor agonist approved by the FDA in May 2022 for type 2 diabetes management. Its unique mechanism and promising efficacy have positioned it as a leading contender in the metabolic therapeutics sector. This analysis provides a comprehensive review of recent clinical trial developments, current market dynamics, competitive landscape, and future market projections.

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What Are the Latest Developments in MOUNJARO's Clinical Trials?

Clinical Trial Status and Recent Results

• Phase 3 Trials: The SURPASS program, consisting of multiple pivotal trials, forms the backbone of Mounjaro's clinical data. Key studies include:

  • SURPASS-2: Demonstrated superior HbA1c reduction compared to semaglutide (a leading GLP-1 receptor agonist) with a significant weight loss advantage.
  • SURPASS-3: Confirmed efficacy as monotherapy and with basal insulin.
  • SURPASS-4: Focused on patients with comorbidities like cardiovascular disease.

• Cardiovascular Outcomes: The SURPASS-CVOT trial announced in 2022 indicated that Mounjaro does not increase cardiovascular risk and suggests potential cardiovascular benefits, aligning with FDA requirements for diabetes drugs.

Ongoing and Future Trials

• SURMOUNT-1: An imminent pivotal trial assessing Mounjaro's efficacy in obesity, with Phase 3 data expected in 2023. This marks a strategic move into weight management markets.
• Additional Indications:
  • Polycystic Ovary Syndrome (PCOS)
  • Nonalcoholic Steatohepatitis (NASH)
• Safety Profile:
  • Generally well-tolerated.
  • Common adverse events: gastrointestinal disturbances (nausea, diarrhea).
  • Rare but serious risks: pancreatitis, medullary thyroid carcinoma (molecular safety assessments ongoing).

Implications of Clinical Data

Clinical trial data support Mounjaro’s positions as:

• Superior in glycemic control.
• Effective in weight reduction.
• Safe with manageable adverse effects.
• Potentially broadening use beyond diabetes into obesity and associated metabolic syndromes.

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Market Analysis of MOUNJARO

Current Market Position

Parameter	Details
FDA Approval Date	May 13, 2022
Indications	Type 2 diabetes; potential obesity indication approval pending
Retail Price (2023)	~$974/month (approximate, varies by region and insurance coverage)
Sales (Q4 2022)	$158 million (initial launch phase)
Market Share (2023)	Estimated 10% within GLP-1 class, second only to semaglutide (Ozempic, Wegovy)

Competitive Landscape

Drug	Manufacturer	Class	Indication	Market Share (2023)	Key Advantages	Limitations
Mounjaro	Eli Lilly	GIP/GLP-1 receptor agonist	T2D, Obesity	~10%	Superior efficacy in trials	Limited long-term data
Ozempic (semaglutide)	Novo Nordisk	GLP-1 receptor agonist	T2D, Obesity	~60%	Established efficacy, wide approval	Gastrointestinal adverse effects
Wegovy	Novo Nordisk	GLP-1 receptor agonist	Obesity	Growing rapidly	Approved explicitly for obesity	Costly, injection frequency
Trulicity	Eli Lilly	GLP-1 receptor agonist	T2D	~20%	Long duration of action	Gastrointestinal effects

Market Drivers and Barriers

• Drivers:

  • Superior efficacy profile.
  • Growing prevalence of T2D and obesity.
  • Favorable safety profile.
  • Preference for injectable therapeutics with sustained action.

• Barriers:

  • High cost and reimbursement hurdles.
  • Competition from oral medications (e.g., oral semaglutide).
  • Manufacturing scalability.
  • Long-term safety data.

Market Projections (2023-2028)

• Global Diabetes Drugs Market:
  • Valued at $62 billion in 2022.
  • Expected CAGR of 7.8% (2023-2028).
• GLP-1/dual GIP-GLP-1 Market:
  • Estimated to reach $35 billion by 2028.
  • Mounjaro anticipated to capture 15-20% of the market due to superior efficacy.

Estimated Revenue and Sales Growth

Year	Predicted Revenue	Key Factors
2023	$500 million	Initial adoption; clinical trials influence
2024	$1.5 billion	Expanded approvals; insurance coverage
2025	$3 billion	Increased market penetration + obesity indication
2026+	$5-10 billion	Potential global blockbuster status

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Market Opportunities and Challenges

Opportunities

• Obesity Market Expansion: Data from SURMOUNT-1 suggests Mounjaro could be transformative, potentially capturing significant share with overweight/obese populations.
• Cardiometabolic Benefits: Ongoing research could differentiate Mounjaro through demonstrated cardiovascular advantages.
• Expansion into Additional Indications: PCOS, NASH, and other metabolic syndromes represent multibillion-dollar potential.

Challenges

• Pricing and Reimbursement: High costs necessitate negotiations with payers.
• Long-Term Safety and Efficacy: Patients and providers will demand extensive evidence beyond initial trials.
• Market Penetration: Existing dominance of semaglutide-based therapies.

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Comparison with Major Competitors

Aspect	Mounjaro	Ozempic/Wegovy	Trulicity
Mechanism	Dual GIP/GLP-1 agonist	GLP-1 receptor agonist	GLP-1 receptor agonist
Efficacy (HbA1c Reduction)	~2.0% in trials	~1.5%-1.8%	~1.3%-1.5%
Weight Loss	Significant (~15-20 lbs)	Significant (~15-20 lbs)	Moderate (~8-10 lbs)
Dosing Frequency	Weekly	Weekly	Weekly
Side Effects	GI disturbances, rare pancreatitis	GI disturbances, thyroid concerns	GI disturbances

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Key Takeaways

• Innovation Driver: Mounjaro's dual GIP and GLP-1 mechanism offers superior glycemic and weight control, positioning it as a competitive leader.
• Market Potential: Estimated to reach $10 billion in revenue by 2028, driven by expanding indications and superior efficacy.
• Clinical Validation: Ongoing trials (SURMOUNT-1, SURPASS-CVOT) will further bolster market confidence.
• Competitive Edge: Its efficacy surpasses traditional GLP-1 receptor agonists, but market share depends on reimbursement strategies, safety perceptions, and long-term data.
• Future Outlook: Mounjaro's market trajectory will hinge on broader approvals, formulary acceptance, and successful expansion into obesity and cardiometabolic indications.

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FAQs

1. How does Mounjaro's mechanism differ from other GLP-1 therapies?

Mounjaro activates both GIP and GLP-1 receptors, providing dual agonism that enhances insulin secretion and weight loss beyond current GLP-1 receptor-only therapies.

2. When will Mounjaro be approved for obesity?

Results from the SURMOUNT-1 trial are expected in 2023, with potential regulatory submission in late 2023 or early 2024, aiming for obesity indication approval shortly thereafter.

3. What are the key safety concerns associated with Mounjaro?

While generally well-tolerated, gastrointestinal side effects are common. Rare but severe risks include pancreatitis and thyroid tumors, requiring ongoing safety evaluations.

4. How does Mounjaro compare cost-wise to competitors?

Pricing is similar to other injectable therapies (~$974/month), but cost-effectiveness will influence payer acceptance and patient access.

5. What is the outlook for Mounjaro's global market penetration?

Strong in developed markets; global expansion depends on regulatory approvals, manufacturing capacity, and tailoring pricing strategies to different healthcare systems.

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References

[1] Eli Lilly. (2023). Mounjaro (tirzepatide) Prescribing Information.
[2] FDA. (2022). Approval Letter for Mounjaro.
[3] Market Research Future. (2023). Global Diabetes Medications Market Analysis.
[4] Eli Lilly. (2022). SURPASS Clinical Trial Publications.
[5] Novo Nordisk. (2023). Semaglutide Market Data.