CLINICAL TRIALS PROFILE FOR EGRIFTA

All Clinical Trials for Egrifta

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00608023 ↗	TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy	Completed	Theratechnologies	Phase 3	2007-08-01	HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations made during the first Phase 3 study.
NCT01579695 ↗	Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®	Terminated	Theratechnologies		2013-02-01	The purpose of this observational, 10-year, prospective cohort study is to assess the potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.
NCT01591902 ↗	Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®	Terminated	Theratechnologies	Phase 4	2012-06-01	To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and Type 2 diabetes mellitus (T2DM).
NCT01788462 ↗	Egrifta Replacement and Sleep Disordered Breathing	Withdrawn	Johns Hopkins University		2012-05-01	Sleep-disordered breathing is characterized primarily by partial or total upper airway obstruction during sleep. The most common form of sleep-disordered breathing is obstructive sleep apnea (OSA) due to recurrent collapse of the upper airway with the onset of sleep state. The major risk factors associated with the development of sleep apnea are obesity and male sex. The investigators have also found a high prevalence of OSA in HIV infected men and women, particularly among those with central lipohypertrophy, which is a common finding in HIV-infected persons receiving antiretroviral therapy. Currently, our overall hypothesis is that visceral adiposity, as seen in HIV-infected persons with central lipohypertrophy, alters both mechanical properties and compensatory neuromuscular responses leading to upper airway obstruction. Based on our most recent findings in the non-HIV population, the investigators demonstrate that obesity is associated with elevations in the upper airway load (passive Pcrit) that are counterbalanced by compensatory upper airway neural responses. Moreover, the investigators have found that female sex, peripheral adiposity, and younger age are associated with increased compensatory neuromuscular responses, while male sex, central adiposity, and older age are associated with blunted compensatory responses. The loss of the compensatory neuromuscular responses leads to obstructive sleep apnea. Among HIV-infected patients with central lipohypertrophy, tesamorelin (Egrifta), a growth hormone releasing hormone (GHRH) analogue, is approved for the reduction of visceral adipose tissue. The investigators hypothesize that tesamorelin therapy will reverse both the mechanical and neurocompensatory alterations associated with increased central obesity. In this project the investigators will determine whether tesamorelin affects sleep apnea severity and compensatory neuromuscular responses of the upper airway on sleep and breathing in men and women with HIV infection. The proposed studies are designed to elucidate the pathophysiologic basis for the development of obstructive sleep apnea in this population. The studies also provide insights into the neurohumoral regulation of upper airway function, and potentially new approaches to the treatment for sleep-disordered breathing.
NCT02012556 ↗	Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients	Completed	Theratechnologies	Phase 1	2008-05-01	The primary objective of the study is to determine the PK (tesamorelin) and PD (IGF-1) profiles of tesamorelin after a single 2 mg subcutaneous administration and after repeated administration once daily for 14 consecutive days. Secondary objectives include the evaluation of the safety and tolerability of tesamorelin following multiple subcutaneous injections.

Clinical Trial Conditions for Egrifta

Condition Name

Condition Name for Egrifta
Intervention	Trials
HIV	3
Lipodystrophy	2
Mild Cognitive Impairment	2
Body Composition	1

Condition MeSH

Condition MeSH for Egrifta
Intervention	Trials
Lipodystrophy	3
Mild Cognitive Impairment	2
HIV-Associated Lipodystrophy Syndrome	2
Cognitive Dysfunction	2

Clinical Trial Locations for Egrifta

Trials by Country

Trials by Country for Egrifta
Location	Trials
United States	48
Canada	4
Belgium	1
United Kingdom	1
Spain	1

Trials by US State

Trials by US State for Egrifta
Location	Trials
California	4
Texas	4
Florida	3
Maryland	3
Washington	3

Clinical Trial Progress for Egrifta

Clinical Trial Phase

Clinical Trial Phase for Egrifta
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Egrifta
Clinical Trial Phase	Trials
Completed	4
Recruiting	3
Terminated	2

Clinical Trial Sponsors for Egrifta

Sponsor Name

Sponsor Name for Egrifta
Sponsor	Trials
Theratechnologies	4
Johns Hopkins University	2
United States Department of Defense	1

Sponsor Type

Sponsor Type for Egrifta
Sponsor	Trials
Other	9
Industry	4
NIH	2

Egrifta (Tesamorelin): Clinical Trials, Market Analysis, and Projections

Introduction

Egrifta, also known as tesamorelin, is a growth hormone-releasing factor (GHRF) analog used primarily to treat excess abdominal fat (visceral adipose tissue or VAT) in HIV-infected patients with lipodystrophy. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

The efficacy and safety of Egrifta were established through two pivotal Phase III clinical studies: LIPO-010 and the combined studies CTR-1011 and CTR-1012[3].

Primary Efficacy Outcomes

The primary efficacy endpoint was the reduction in VAT, measured by abdominal computed tomography (CT) scans. In both trials, significant reductions in VAT exceeding the clinically meaningful threshold of 8% were observed. For example, in Trial 10, VAT decreased by 18% in the Egrifta group compared to a 2% increase in the placebo group, with a mean treatment difference of -20% (-24% to -15%)[1].

Secondary Efficacy Outcomes

Secondary endpoints included effects on lipid profiles and individual-reported outcomes related to body image. While the FDA questioned the content validity of the scale used to assess body image, the trials showed improvements in these areas. For instance, the mean between-group difference in improvement for belly appearance distress was 5.4 points in Trial 10 and 3.1 points in Trial 11[1].

Safety and Adverse Events

Common adverse events associated with Egrifta treatment included hypersensitivity reactions (e.g., rash, urticaria), arthralgia, peripheral edema, and hyperglycemia. There were no clinically significant changes in fasting blood glucose, fasting serum insulin, or HbA1c levels during the main trials, although the proportion of individuals with HbA1c in the diabetic range increased in the Egrifta group during the main phase[1].

Long-Term Safety

Long-term safety is being monitored through post-marketing studies, including a 3-year study on the effects of tesamorelin on diabetic retinopathy and a 10-year observational cohort study to monitor cardiovascular safety[3].

Market Analysis

Current Market Status

Egrifta is exclusively distributed in the United States and has been a critical treatment option for HIV-infected patients with lipodystrophy. However, recent production challenges have impacted its availability. A voluntary shutdown of the contract manufacturer's facility due to FDA inspection observations led to a temporary supply disruption risk in early 2025[2][5].

Production Resumption

Theratechnologies has announced the resumption of Egrifta production, with one batch completing quality control and two additional batches in production. Current inventory is managed to meet patient demand until mid-January 2025, and the company is working closely with the FDA to prevent potential supply shortages[5].

Revenue Impact

The temporary supply disruption is expected to result in a revenue shortfall of approximately $1.6 million for Theratechnologies' fiscal year 2024. Despite this, the company remains confident in delivering a strong Adjusted EBITDA for the current fiscal year[2].

Market Projections

Demand and Growth

The demand for Egrifta is expected to remain strong due to its unique position in treating excess abdominal fat in HIV-infected patients. As the HIV population ages, the need for effective treatments for lipodystrophy and associated metabolic issues is likely to increase.

New Formulations

Theratechnologies has submitted a supplemental Biologics License Application (sBLA) for an F8 formulation of tesamorelin, intended to replace Egrifta SV with simplified dosing. This new formulation is expected to enhance patient compliance and address clinical challenges more effectively[4].

Regulatory Pathway

The regulatory pathway for Egrifta, including the new F8 formulation, will be crucial. The FDA's review process for the Prior Approval Supplement and the sBLA will determine the timeline for market availability. Successful navigation of these regulatory hurdles is essential for maintaining and expanding market presence[4][5].

Competitive Landscape

Egrifta operates in a niche market with limited competition for the specific indication of reducing VAT in HIV-infected patients. However, the introduction of new formulations and treatments for metabolic disorders associated with HIV could potentially alter the competitive landscape.

Key Takeaways

• Clinical Efficacy: Egrifta has demonstrated significant reductions in VAT and improvements in body image and lipid profiles.
• Safety Profile: Common adverse events include hypersensitivity reactions and hyperglycemia, with ongoing monitoring for long-term safety.
• Market Challenges: Recent production shutdowns due to FDA inspections have led to temporary supply disruptions, but production has resumed.
• Market Projections: Strong demand is expected due to the growing need for effective treatments for lipodystrophy in HIV patients.
• Regulatory Pathway: Successful FDA approvals for new formulations and ongoing regulatory compliance are critical for market stability.

FAQs

What is Egrifta used for?

Egrifta (tesamorelin) is used to treat excess abdominal fat (visceral adipose tissue or VAT) in HIV-infected patients with lipodystrophy.

What were the primary outcomes of the clinical trials for Egrifta?

The primary efficacy endpoint was a reduction in VAT, with significant reductions exceeding the clinically meaningful threshold of 8% observed in both trials.

What are the common adverse events associated with Egrifta?

Common adverse events include hypersensitivity reactions (e.g., rash, urticaria), arthralgia, peripheral edema, and hyperglycemia.

Is there a risk of supply disruption for Egrifta?

Yes, there was a risk of temporary supply disruption in early 2025 due to a voluntary shutdown of the contract manufacturer's facility, but production has resumed.

What new developments are expected for Egrifta?

Theratechnologies has submitted a sBLA for an F8 formulation of tesamorelin, which is intended to replace Egrifta SV with simplified dosing.

Sources

1. LifeWise Assurance Company - 5.01.530 Egrifta SV® (tesamorelin) - LifeWise Assurance Company
2. Theratechnologies - Theratechnologies Announces a Risk of a Temporary Supply Disruption for EGRIFTA SV
3. Health Canada - Summary Basis of Decision for Egrifta
4. Theratechnologies - Theratechnologies Submits Tesamorelin F8 Formulation sBLA for FDA
5. Stock Titan - Theratechnologies Announces Resumed Production of EGRIFTA SV

Last updated: 2025-01-01