You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: April 20, 2025

CLINICAL TRIALS PROFILE FOR SEROSTIM LQ


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Serostim Lq

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00071240 ↗ Growth Hormone to Increase Immune Function in People With HIV Completed EMD Serono Phase 2 2002-10-01 Growth hormone plays an important role in the development of the immune system. Studies suggest that growth hormone may promote growth of the thymus, a gland responsible for the production of important immune cells called T cells. Since these cells are lost during the course of HIV infection, it is possible that growth hormone treatment could help restore the immune system. This study will determine whether the administration of growth hormone can increase the size and function of the thymus and cause an increase in the number of new T cells in the blood of people infected with HIV. Study hypothesis: Growth hormone treatment will enhance T cell production in HIV infected adults.
NCT00071240 ↗ Growth Hormone to Increase Immune Function in People With HIV Completed National Center for Research Resources (NCRR) Phase 2 2002-10-01 Growth hormone plays an important role in the development of the immune system. Studies suggest that growth hormone may promote growth of the thymus, a gland responsible for the production of important immune cells called T cells. Since these cells are lost during the course of HIV infection, it is possible that growth hormone treatment could help restore the immune system. This study will determine whether the administration of growth hormone can increase the size and function of the thymus and cause an increase in the number of new T cells in the blood of people infected with HIV. Study hypothesis: Growth hormone treatment will enhance T cell production in HIV infected adults.
NCT00071240 ↗ Growth Hormone to Increase Immune Function in People With HIV Completed The J. David Gladstone Institutes Phase 2 2002-10-01 Growth hormone plays an important role in the development of the immune system. Studies suggest that growth hormone may promote growth of the thymus, a gland responsible for the production of important immune cells called T cells. Since these cells are lost during the course of HIV infection, it is possible that growth hormone treatment could help restore the immune system. This study will determine whether the administration of growth hormone can increase the size and function of the thymus and cause an increase in the number of new T cells in the blood of people infected with HIV. Study hypothesis: Growth hormone treatment will enhance T cell production in HIV infected adults.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Serostim Lq

Condition Name

Condition Name for Serostim Lq
Intervention Trials
HIV Infections 5
Human Immunodeficiency Virus Infections 2
Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS) 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Serostim Lq
Intervention Trials
HIV Infections 7
Syndrome 3
Lipodystrophy 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Serostim Lq

Trials by Country

Trials by Country for Serostim Lq
Location Trials
United States 19
Canada 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Serostim Lq
Location Trials
New York 4
Massachusetts 2
California 2
Washington 1
Virginia 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Serostim Lq

Clinical Trial Phase

Clinical Trial Phase for Serostim Lq
Clinical Trial Phase Trials
Phase 3 2
Phase 2/Phase 3 2
Phase 2 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Serostim Lq
Clinical Trial Phase Trials
Completed 7
Active, not recruiting 1
Enrolling by invitation 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Serostim Lq

Sponsor Name

Sponsor Name for Serostim Lq
Sponsor Trials
EMD Serono 5
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 2
Massachusetts General Hospital 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Serostim Lq
Sponsor Trials
Other 6
Industry 5
NIH 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Serostim LQ: Clinical Trials, Market Analysis, and Projections

Introduction

Serostim LQ, a recombinant human growth hormone (somatropin), is used primarily for the treatment of HIV-associated wasting or cachexia. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Efficacy in HIV-Associated Wasting

Clinical trials have demonstrated the efficacy of Serostim LQ in treating HIV-associated wasting. In two placebo-controlled trials, Serostim LQ showed statistically significant increases in lean body mass (LBM), body weight, and improvements in physical endurance[4][5].

  • Trial Design: These trials were 12-week, randomized, double-blind, and placebo-controlled, followed by an open-label extension phase. Patients received either placebo or Serostim LQ at doses of approximately 0.1 mg/kg daily or every other day[4][5].
  • Outcomes: The trials revealed that Serostim LQ increased LBM and body weight significantly compared to the placebo group. For instance, after 12 weeks, the mean difference in weight increase was 1.6 kg (3.5 lb), and the mean difference in LBM change was 3.1 kg (6.8 lbs) between the Serostim LQ-treated group and the placebo group[5].
  • Physical Endurance: Treadmill exercise testing showed a median increase in work output by 13% in the Serostim LQ-treated group, indicating improved physical function[5].

Adverse Reactions

Common adverse reactions associated with Serostim LQ include edema, arthralgia, pain in extremity, hypoesthesia, myalgia, and increased blood glucose levels. These symptoms often subsided with dose reduction[1][3].

  • Hyperglycemia and Diabetes: The incidence of hyperglycemia was reported in 3.6% of the placebo group, 1.9% of the 0.1 mg/kg every other day group, and 3.2% of the 0.1 mg/kg daily group. One case of diabetes mellitus was noted in the daily dose group during the first 12 weeks, and additional cases were reported during the extension phase[1][3].

Market Analysis

Global Somatropin Market

The global somatropin market, which includes Serostim LQ, is projected to grow significantly.

  • Market Size and Growth: The global somatropin market is estimated to be valued at US$ 3.85 billion in 2023 and is expected to exhibit a Compound Annual Growth Rate (CAGR) of 7.3% during the forecast period from 2023 to 2030, reaching a projected value of US$ 6.30 billion by 2030[2].
  • Key Drivers: The growth is driven by rising product approvals, new product launches by major market players, and the increasing long-term effects of growth hormone therapy on children with growth hormone deficiency and other conditions like Turner syndrome[2].

Distribution Channels

The market is segmented by distribution channels, with hospital pharmacies expected to dominate due to the preference and ease of availability of somatropin products in these settings.

  • Regional Dominance: North America is expected to dominate the market due to the increase in product launches and the prevalence of conditions like Turner syndrome[2].

Application Segment

The application segment has the highest potential due to increasing product launches and the rising prevalence of conditions such as Turner syndrome, which affects approximately 1 in every 2,000 to 2,500 live female births in the U.S.[2].

Market Projections

Future Growth

The somatropin market, including Serostim LQ, is poised for significant growth driven by several factors:

  • Regulatory Approvals: Continued regulatory approvals for new indications and formulations will drive market expansion[2].
  • Clinical Trials: Ongoing and future clinical trials, such as the Phase III trial assessing the effect of growth hormone treatment on adults with Prader-Willi syndrome, will contribute to market growth[2].
  • Recovery from COVID-19 Impact: The market has shown recovery from the disruptions caused by the COVID-19 pandemic, indicating a strong potential for future growth[2].

Competitive Landscape

The market is competitive, with several key players including Novo Nordisk A/S, Pfizer, Inc., Eli Lilly and Company, and others. These companies are continuously innovating and expanding their product portfolios, which will further drive market growth[2].

Key Takeaways

  • Clinical Efficacy: Serostim LQ has demonstrated significant efficacy in treating HIV-associated wasting, increasing LBM, body weight, and physical endurance.
  • Market Growth: The global somatropin market is expected to grow at a CAGR of 7.3% from 2023 to 2030, driven by regulatory approvals, new product launches, and increasing prevalence of relevant conditions.
  • Distribution and Region: Hospital pharmacies and the North American region are expected to dominate the market.
  • Adverse Reactions: Common adverse reactions include edema, arthralgia, and increased blood glucose levels, which often subside with dose reduction.

FAQs

What is Serostim LQ used for?

Serostim LQ is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body weight and improve physical endurance.

What are the common adverse reactions associated with Serostim LQ?

Common adverse reactions include edema, arthralgia, pain in extremity, hypoesthesia, myalgia, and increased blood glucose levels.

How does Serostim LQ impact physical endurance?

Clinical trials have shown that Serostim LQ significantly improves physical endurance, as measured by treadmill exercise testing, with a median increase in work output by 13%.

What is the projected market size of the global somatropin market by 2030?

The global somatropin market is projected to reach US$ 6.30 billion by 2030.

Which region is expected to dominate the somatropin market?

North America is expected to dominate the market due to the increase in product launches and the prevalence of conditions like Turner syndrome.

Sources

  1. Serostim® LQ [somatropin (rDNA origin) injection] - FDA Label.
  2. Somatropin Market - Share, Size and Industry Analysis - Coherent Market Insights.
  3. SEROSTIM (somatropin) for injection, for subcutaneous use - EMD Serono.
  4. Serostim® (somatropin) for injection Clinical Trial Results - Serostim.
  5. Serostim® Clinical Profile - Serostim.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.