A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study to Evaluate the Efficacy and Safety of CJC 1295 Administered for 12 Weeks in HIV Infected Patients With HIV Associated Visceral Obesity

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00267527

Enrollment

120

Registered

2005-12-21

Start date

2005-12-31

Completion date

2006-09-30

Last updated

2006-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Obesity

Keywords

Treatment Experienced, HIV Visceral Obesity

Brief summary

This is a multicenter, randomized, placebo-controlled, double-blind, Phase 2 study. Patients will be treated for a total of 12 weeks. There will be a 6 week follow-up period after the treatment period ends. Patients will be randomly assigned to low dose CJC 1295, high dose CJC 1295 or placebo. The objective is to assess and compare the efficacy, pharmacokinetics, safety, and tolerability of CJC 1295 in patients with human immunodeficiency virus (HIV) associated visceral obesity.

Interventions

DRUGCJC 1295

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age 18-65 on stable antiviral regimen * Documented HIV infection * HIV associated visceral obesity * Body mass index (BMI) \> 24 and \< 30 kg/m2

Exclusion criteria

* Diabetes * Use of growth hormone (GH) or other GH secretagogues * Use of systemic glucocorticoids, * Use of megestrol acetate or other appetite stimulants, * Use of general anorexigenic or weight-reducing agents, or * Use of androgens, other than testosterone replacement therapy for male hypogonadism at physiological doses and on a stable regimen for at least 6 months prior to randomization.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026