Compound library/Primary-source evidence guide

AOD-9604

Obesity-development history and the gap between early studies and online fat-loss claims

AOD-9604 is a modified fragment related to human growth hormone research. It is widely marketed for fat loss, but online claims often omit the distinction between early mechanistic or development studies and evidence needed for an approved obesity medicine.

Editorial status

This page aggregates regulatory documents and published human research. Its claims, citations, populations, and limitations received an independent editorial evidence check. Last editorial audit: .

It has not been medically reviewed by a clinician. It provides general education, not diagnosis, treatment, dosing instructions, or advice for an individual. Use the product-specific official information and consult a qualified clinician or pharmacist for personal decisions.

Product and regulatory distinctions

A compound name is not one interchangeable set of instructions. Product, formulation, indication, labeling, and jurisdiction matter.

AOD-9604 drug products

This guide does not identify a current FDA-approved AOD-9604 drug product.

Current source

Compounded or online AOD-9604

Compounded products are not FDA-approved and are not reviewed by FDA before marketing for safety, effectiveness, or quality.

Current source

Sport context

Athletes should verify growth-hormone fragment status with current anti-doping rules.

Current source

Claim-by-claim evidence map

Each finding is tied to the population and product actually studied. Trial results are not personal predictions.

Randomized human trial

The pivotal 24-week obesity study described by FDA did not show significant weight loss with AOD-9604 versus placebo.

Population
502 randomized adults aged 18 to 65 with obesity in the OPTIONS study, receiving oral AOD-9604 or placebo with supervised diet and exercise.
Finding
FDA's 2024 review reports no statistically significant weight-loss difference at 12 or 24 weeks and notes that the sponsor terminated obesity development.
Limits
FDA did not locate a full publication; available summaries lacked complete methods and results, and oral study findings cannot validate gray-market injectable products.
Preclinical evidence

AOD-9604 changed weight-gain and lipid-metabolism measures in an obese-rat model.

Population
Obese Zucker rats treated orally for 19 days.
Finding
The study reported reduced body-weight gain and increased adipose lipolytic activity.
Limits
An animal mechanism result cannot establish human weight-loss efficacy, dose, durability, or safety; the later human OPTIONS study did not show significant weight loss.
Unsupported or anecdotal

FDA found the available evidence insufficient to support effectiveness and identified unresolved safety limitations for nominated compounded uses.

Population
U.S. regulatory review of AOD-9604 for compounding-policy purposes.
Finding
The review described incomplete clinical reporting and limited nonclinical safety evidence, including unresolved genotoxicity and product-use questions.
Limits
This regulatory assessment does not prove that every individual product is defective and does not replace product-specific testing.

What this evidence does not answer

  • No current FDA-approved obesity indication is identified here.
  • Claims about targeted fat loss, cartilage, or metabolic safety require product-specific human evidence.
  • Long-term safety outside studied protocols is not established.

Useful information to organize between visits

  • Product name and source
  • Reason for interest and concurrent weight-management treatments
  • Objective measures tracked by a clinician
  • Any adverse symptoms or injection-site reactions

Questions to bring to a clinician or pharmacist

  1. 1.What approved options fit my weight or metabolic condition?
  2. 2.Does any human trial support this exact product and goal?
  3. 3.What risks exist with endocrine or metabolic history?

Primary sources

  1. AOD-9604: Pharmacy Compounding Advisory Committee briefing documentU.S. Food and Drug Administration · Published 2024 · Accessed July 12, 2026
  2. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormoneHormone Research · Published 2000 · Accessed July 12, 2026
  3. Drugs@FDA: FDA-Approved DrugsU.S. Food and Drug Administration · Published Current database · Accessed July 12, 2026
  4. Compounded Drugs: Questions and AnswersU.S. Food and Drug Administration · Published Current guidance · Accessed July 12, 2026
  5. 2026 Prohibited ListWorld Anti-Doping Agency · Published 2026 · Accessed July 12, 2026

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