Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (IMPACT Trial)

• Sponsor: Altimmune, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05989711
• Collaborator: (none)
• Enrollment: 190
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 26.2
• Patients Per Site: 95
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Steatohepatitis (NASH)	Drug: Pemvidutide; Drug: Placebo	Phase 2

Detailed Description

A Phase 2, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in NASH.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, Double-blind, Placebo-controlledRandomized, Double-blind, Placebo-controlled
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)
• Actual Study Start Date: Jul 27, 2023
• Anticipated Primary Completion Date: Feb 28, 2025
• Anticipated Study Completion Date: Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pemvidutide 1.2 mg (n=38)	Drug: Pemvidutide; Administered by subcutaneous injection
Experimental: Pemvidutide 1.8 mg (n=76)	Drug: Pemvidutide; Administered by subcutaneous injection
Placebo Comparator: Placebo (n=76)	Drug: Placebo; Administered by subcutaneous injection

Outcome Measures

Primary Outcome Measures

1. Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis [24 weeks]

2. Proportion of subjects achieving at least 1 stage improvement in liver fibrosis without worsening of NASH (defined as no change in the NAS, ie, the sum score for ballooning, inflammation, and steatosis) [24 weeks]

Secondary Outcome Measures

1. Proportion of subjects achieving the composite of both NASH resolution and at least 1 stage improvement of liver fibrosis at 24 weeks [24 weeks]

2. Relative change (%) in liver fat content by MRI-PDFF [24 weeks and 48 weeks]

3. Absolute change in MRI-based corrected T1 (cT1) imaging [24 weeks and 48 weeks]

4. Absolute change in alanine aminotransferase (ALT) [24 weeks and 48 weeks]

5. Absolute change in Enhanced Liver Fibrosis (ELF) score [24 weeks and 48 weeks]

6. Absolute change in Fibroscan-AST (FAST) score [24 weeks and 48 weeks]

7. Relative (%) change in body weight [24 weeks and 48 weeks]

8. Absolute changes in fasting lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) [24 weeks and 48 weeks]

9. Change in HbA1c (%) [24 weeks and 48 weeks]

10. Change in glucose (mg/dL) [24 weeks and 48 weeks]

11. Change in systolic and diastolic blood pressure (mmHg) [24 weeks and 48 weeks]

12. Change in heart rate (beats per minute) [24 weeks and 48 weeks]

13. The number of subjects with treatment emergent adverse events [48 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Written informed consent

2. Male or female 18-75 years

3. Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening

4. A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1 on each subcomponent score based on central pathology evaluation (steatosis [0-3], lobular inflammation [0-3], and hepatocyte ballooning [0-2])

5. NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis staging system based on central pathology evaluation

6. Subject agrees to have a liver biopsy performed during the screening period (if no biopsy within the preceding 6 months is available) and at 24 weeks of treatment

7. BMI ≥ 27.0 kg/m2

8. Subjects with Type 2 diabetes mellitus (T2D) should be on a stable treatment regimen for their T2D for at least 90 days prior to screening

9. Subject meets at least 3 of the 5 criteria of Metabolic Syndrome (American Heart Association 2005)

10. Liver fat content by MRI-PDFF ≥ 8%

Exclusion Criteria:

1. Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening

2. History or clinical evidence of Type 1 diabetes mellitus

3. Hemoglobin A1c (HbA1c) > 9.5% or clinically significant persistent hyperglycemia

4. Liver conditions:

5. History of cirrhosis or complications of cirrhosis, including but not limited to variceal bleeding, encephalopathy, or ascites

6. Documented causes of chronic liver disease other than NASH

7. ALT or AST laboratory values > 5 × ULN

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altimmune Clinical Study Site	Fort Myers	Florida	United States	33912
2	Altimmune Clinical Study Site	Sarasota	Florida	United States	34240

Sponsors and Collaborators

• Altimmune, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Altimmune, Inc.
• ClinicalTrials.gov Identifier: NCT05989711
• Other Study ID Numbers: ALT- 801-203
• First Posted: Aug 14, 2023
• Last Update Posted: Aug 14, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Aug 14, 2023