NCT03960541: CALIBER

Efprezimod Alfa (CD24Fc, MK-7110) Administration to Decrease Low-Density Lipoprotein (LDL) and Inflammation in Human Immunodeficiency Virus (HIV) Patients (CALIBER) (MK-7110-003)

Terminated Phase 2 Results posted Last updated 8 February 2023

What this trial tests

Phase 2 trial testing Efprezimod alfa (human CD24 extracellular domain and human IgG1 Fc fusion protein) in HIV Infections in 8 participants. Terminated before completion.

Timeline

31 August 2020

Primary endpoint
27 May 2021

27 May 2021

Quick facts

Lead sponsor	Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	8
Start date	31 August 2020
Primary completion	27 May 2021
Estimated completion	27 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Efprezimod alfa (human CD24 extracellular domain and human IgG1 Fc fusion protein) — full drug profile →
• Saline Solution

Conditions studied

• HIV Infections — all drugs for HIV Infections →
• Dyslipidemias — all drugs for Dyslipidemias →

Sponsor

Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full company profile →

Who can join

50 and older, any sex, with HIV Infections or Dyslipidemias. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) Primary · Baseline and Week 6

LDL-C was measured in participant serum. The percent change from baseline at Week 6 is presented.

Group	Value	95% CI
CD24Fc 240 mg	6.24	± 6.392
Placebo	6.51	± 19.690

Number of Participants With ≥1 Adverse Event (AE) Primary · Up to approximately 28 weeks

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any worsening of a preexisting condition which is temporally associated with the use of the study treatment is also considered an AE. The number of participants who experienced an AE is presented.

Group	Value	95% CI
CD24Fc 240 mg	4
Placebo	4

Number of Participants Who Withdrew From Study Treatment Due to an AE Primary · Up to approximately 4 weeks

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any worsening of a preexisting condition which is temporally associated with the use of the study treatment is also considered an AE. The number of participants who withdrew from study treatment due to an AE is presented.

Group	Value	95% CI
CD24Fc 240 mg	0
Placebo	0

Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein-Cholesterol (HDL-C), and Triglycerides Secondary · Baseline, Week 6, and Week 28

Total cholesterol, HDL-C, and triglycerides were measured in participant serum. The percent change from baseline at Weeks 6 and 28 for these lipid panel results is presented.

Percent Change from Baseline in Total Cholesterol at Week 6

Group	Value	95% CI
CD24Fc 240 mg	4.66	± 5.850
Placebo	1.53	± 10.947

Percent Change from Baseline in HDL-C at Week 6

Group	Value	95% CI
CD24Fc 240 mg	6.69	± 12.250
Placebo	0.88	± 6.655

Percent Change from Baseline in Triglycerides at Week 6

Group	Value	95% CI
CD24Fc 240 mg	-8.42	± 24.982
Placebo	-7.30	± 23.607

Percent Change from Baseline in Total Cholesterol at Week 28

Group	Value	95% CI
CD24Fc 240 mg	5.61	± 21.672
Placebo	2.40	± 18.037

Percent Change from Baseline in HDL-C at Week 28

Group	Value	95% CI
CD24Fc 240 mg	0.30	± 0.610
Placebo	3.20	± 19.512

Percent Change from Baseline in Triglycerides at Week 28

Group	Value	95% CI
CD24Fc 240 mg	-2.77	± 48.320
Placebo	-1.80	± 46.310

Percent Change From Baseline in Controlled Attenuation Parameter (CAP) as Determined by Transient Elastography of the Liver Secondary · Baseline and Week 28

CAP is a measure related to hepatic steatosis. CAP was measured in decibels per meter (dB/m) at baseline and Week 28. The percent change is presented.

Group	Value	95% CI
CD24Fc 240 mg	23.98	± 34.167
Placebo	-5.86	± 33.756

Percent Change From Baseline in Liver Stiffness as Determined by Transient Elastography of the Liver Secondary · Baseline and Week 28

Liver stiffness is a measure related to hepatic fibrosis. Liver stiffness was measured in kilopascals (kPa) at baseline and Week 28. The percent change is presented.

Group	Value	95% CI
CD24Fc 240 mg	-0.81	± 52.168
Placebo	16.16	± 27.449

Percent Change From Baseline in Leptin Secondary · Baseline, Week 6, and Week 28

Leptin concentration was measured in participant serum. The percent change from baseline at Weeks 6 and 28 is presented.

Percent Change from Baseline at Week 6

Group	Value	95% CI
CD24Fc 240 mg	46.72	± 36.104
Placebo	22.43	± 73.205

Percent Change from Baseline at Week 28

Group	Value	95% CI
CD24Fc 240 mg	83.03	± 117.848
Placebo	29.84	± 84.316

Percent Change From Baseline in Glycated Hemoglobin (HbA1c) Secondary · Baseline, Week 6, and Week 28

Glycated hemoglobin (HbA1c) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage HbA1c is the ratio of glycated hemoglobin to total hemoglobin x 100. The percent change from baseline at Weeks 6 and 28 is presented.

Percent Change from Baseline at Week 6

Group	Value	95% CI
CD24Fc 240 mg	0.69	± 3.665
Placebo	-2.71	± 1.070

Percent Change from Baseline at Week 28

Group	Value	95% CI
CD24Fc 240 mg	4.65	± 2.585
Placebo	0.03	± 2.557

Change From Baseline in Apolipoprotein B (apoB) Levels Secondary · Baseline and Week 28

Levels of apoB were measured in participant blood samples collected at baseline and Week 28. The change from baseline level is presented.

Baseline

Group	Value	95% CI
CD24Fc 240 mg	109.0	± 19.34
Placebo	105.0	± 29.31

Change from Baseline

Group	Value	95% CI
CD24Fc 240 mg	-9.8	± 14.75
Placebo	6.5	± 25.09

Change From Baseline in Lipoprotein(a) (Lp[a]) Levels Secondary · Baseline and Week 28

Levels of Lp(a) were measured in participant blood samples collected at baseline and Week 28. The change from baseline level is presented.

Baseline

Group	Value	95% CI
CD24Fc 240 mg	60.38	± 39.443
Placebo	301.45	± 140.645

Change from Baseline

Group	Value	95% CI
CD24Fc 240 mg	-15.03	± 9.662
Placebo	8.40	± 70.528

Change From Baseline in Urine Albumin:Creatinine Ratio Secondary · Baseline and Week 28

The ratio between levels of albumin and creatine was measured in participant urine at baseline and Week 28. The change from baseline in the ratio is presented.

Baseline

Group	Value	95% CI
CD24Fc 240 mg	6.0	± 2.65
Placebo	796.3	± 1322.45

Change from Baseline

Group	Value	95% CI
CD24Fc 240 mg	0.5	± 0.71
Placebo	-357.0	± 434.16

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were monitored for up to approximately 28 weeks. All-Cause Mortality was monitored for up to approximately 36 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CD24Fc 240 mg

Serious: 0/4 (0%)

Deaths: 0/4

Placebo

Serious: 0/4 (0%)

Deaths: 0/4

Other adverse events (23 terms — click to expand)

Reaction	System	CD24Fc 240 mg	Placebo
Hypertension	Vascular disorders	—	—
Sinus bradycardia	Cardiac disorders	—	—
Glomerular filtration rate decreased	Investigations	—	—
Blood albumin decreased	Investigations	—	—
Blood cholesterol increased	Investigations	—	—
Blood glucose increased	Investigations	—	—
International normalised ratio increased	Investigations	—	—
Prothrombin time prolonged	Investigations	—	—
Low density lipoprotein increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Blood potassium decreased	Investigations	—	—
Blood triglycerides increased	Investigations	—	—
CD4 lymphocytes decreased	Investigations	—	—
Coronavirus test positive	Investigations	—	—
Platelet count decreased	Investigations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Myalgia intercostal	Musculoskeletal and connective tissue disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Peripheral swelling	General disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Headache	Nervous system disorders	—	—
Ecchymosis	Skin and subcutaneous tissue disorders	—	—
Papule	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT03960541 adverse events section.

Sponsor's own description

This is a phase 2, randomized, double-blinded, placebo-controlled clinical trial. The intervention drug will be efprezimod alfa (intravenous \[IV\] infusion). A cohort of 64 patients with HIV on antiretroviral therapy (ART) will be randomized in a 1:1 fashion to be administered 3 doses of efprezimod alfa (240mg IV infusion) or placebo once every 2 weeks (q2w) during a 4-week window, followed by a 24-week follow-up window to assess the changes in LDL.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting CD24/Siglec-10 signal pathway for cancer immunotherapy: recent advances and future directions.
   Li X, Tian W, Jiang Z, Song Y, et al · · 2024 · cited 48× · PMID 38279998 · DOI 10.1007/s00262-023-03606-0
2. New hope for tumor immunotherapy: the macrophage-related "do not eat me" signaling pathway.
   Deng H, Wang G, Zhao S, Tao Y, et al · · 2023 · cited 19× · PMID 37484024 · DOI 10.3389/fphar.2023.1228962
3. Is modulation of immune checkpoints on glioblastoma-infiltrating myeloid cells a viable therapeutic strategy?
   Du R, Zhang J, Lukas RV, Tripathi S, et al · · 2025 · cited 9× · PMID 39427326 · DOI 10.1093/neuonc/noae193
4. Surprising magic of CD24 beyond cancer.
   Wang H, Shi P, Shi X, Lv Y, et al · · 2023 · cited 6× · PMID 38313430 · DOI 10.3389/fimmu.2023.1334922
5. Tumor-Associated Macrophages as Therapeutic Targets: Deciphering Interaction Networks and Advancing Clinical Translation.
   Bao W, Qu X, Wang Y, Huang D, et al · · 2026 · PMID 41614207 · DOI 10.1002/mco2.70599