Skip to content
Peptide Evidence Registry

Metabolic & endocrine · Cosmetic & aesthetic

CBL-514

An investigational localized fat-reduction small-molecule injection, studied for abdominal subcutaneous fat reduction rather than whole-body obesity treatment. Not a peptide.

L4Good human trialsIn clinical trialsIn clinical developmentSmall molecule — not a peptide
How settled this rating is:
moderate confidence in the current evidence rating
Routes studied:
Subcutaneous injection
Also known as:
Caliway CBL-514, CBL514
Last reviewed:
2026-10-03
Jump to section

Evidence passport

CBL-514

A one-screen evidence identity for this compound. These fields describe research maturity, confidence and legal status. They are not a safety guarantee, efficacy percentage or recommendation.

Reviewed 2026-10-03
Evidence level
L4Good human trials
Confidence
Moderate confidence in rating
Regulatory status
In clinical trials
Development status
In clinical development

Evidence strength

Human efficacy evidence55 of 100 evidence strength

Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.

Human safety evidence35 of 100 evidence strength

Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.

The 0-100 values rate the strength and maturity of evidence, not how effective or safe the compound is.

Evidence base
Includes human studies
Furthest established stage
Phase III
Human research maturity
Completed controlled Phase 2 and Phase 2b trials for localized abdominal subcutaneous fat reduction; pivotal Phase 3 started September 2026
Source curation
Sources fully curated

Routes recorded

SC injection

Overview

Human efficacy evidence strength55 of 100 evidence strength

Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.

Preclinical (animal / lab) evidence strength45 of 100 evidence strength

Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.

Human safety evidence strength35 of 100 evidence strength

Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.

Evidence for the assessed benefit

L4Good human trialsModerate confidence in rating

Controlled Phase 2/2b evidence supports reduction of treated-area abdominal subcutaneous fat measured by imaging and rating scales. This is local fat reduction (body contouring), not evidence of systemic weight loss, obesity treatment, weight-regain prevention or metabolic benefit.

Human research context: Adults in randomized placebo-controlled abdominal fat-reduction trials published in Aesthetic Surgery Journal; a separate sponsor-reported Phase 2 trial in Dercum's disease.

Research maturity, benefit evidence, safety and approval are different questions.

How to read these scores

Every number here rates the evidence, not the compound. They are editorial 0-100 strength ratings, not percentages, and not a rating out of five stars.

  • Human efficacy evidence strength — Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
  • Preclinical evidence strength — Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
  • Human safety evidence strength — Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number. A score of 80 does not mean “80% safe”.
  • Evidence level (L0-L5) — the strongest type of study behind the compound, from anecdote (L0) to large replicated human trials (L5). It is a description of the study evidence, not a quality, safety or recommendation rating.
  • Confidence — how likely we think it is that this rating changes as new research lands. Low confidence means the picture is unsettled, not that the compound is bad.

None of these ratings is medical advice, a safety guarantee, or a recommendation to use anything. How we grade evidence.

How far human research has progressed: Completed controlled Phase 2 and Phase 2b trials for localized abdominal subcutaneous fat reduction; pivotal Phase 3 started September 2026

Routes & formulations

Studied / approved routes

SC injection

In trials, CBL-514 was injected subcutaneously into abdominal adipose tissue. This describes the trial route only, not a regimen or advice for use.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

    Furthest established stage

  6. Approved

In clinical development

Active development. Phase 3 SUPREME-01 (localized abdominal fat) began dosing in September 2026; an FDA IND for a Phase 2 combination study with tirzepatide (CBL-0201WR) was announced as cleared on 25 August 2026.

Last documented development: 23 September 2026 — first patient dosed in Phase 3 SUPREME-01 (sponsor-reported)

What it is

A small-molecule injectable formulation developed by Caliway Biopharmaceuticals and injected into subcutaneous fat. It is not a peptide; it is listed here because it appears in body-composition and fat-loss discussions alongside peptide medicines.

What people claim

  • Reduces abdominal subcutaneous fat in the injected area
  • Treats obesity or causes weight loss
  • Prevents weight regain after GLP-1 medicines

What the evidence actually says

Two peer-reviewed controlled trials support local abdominal fat reduction. The Phase 2 trial (76 participants, randomized, single-blind, placebo-controlled) reported a significantly greater proportion of CBL-514 participants achieving at least 150 mL abdominal subcutaneous fat reduction versus placebo. The Phase 2b trial (published 20 May 2026) used clinician- and patient-rated abdominal fat scales and MRI; the sponsor summarizes CBL-0205 (173 participants) as 54.2% achieving at least 20% MRI fat-volume reduction four weeks after final treatment, with mean fat-volume reduction of 22.4% versus an increase with placebo. Readers should prefer the peer-reviewed article over sponsor summaries. None of this establishes whole-body obesity efficacy, durability, or functional or metabolic benefit.

Related evidence

Useful next reads based on this compound — not recommendations.

Human evidence

  • Phase 2 (Aesthetic Surgery Journal): 76 participants, randomized, single-blind, placebo-controlled; significantly greater proportion achieving ≥150 mL abdominal subcutaneous fat reduction versus placebo.
  • Phase 2b (Aesthetic Surgery Journal, published 20 May 2026): assessed with clinician/patient abdominal fat rating scales and MRI. Sponsor-reported CBL-0205 summary (173 participants): 54.2% achieved ≥20% MRI fat-volume reduction four weeks after final treatment; mean reduction 22.4% versus an increase with placebo.
  • Dercum's disease Phase 2 (CBL-0202DD), sponsor-reported 21 September 2026: mean pain-score reduction at week 20 of 3.1 versus 1.9 points with placebo in the full analysis set (p=0.005). Not yet peer reviewed in our record, and a separate indication from abdominal fat reduction or obesity.

Preclinical evidence

  • Sponsor-reported preclinical combination data with incretin or amylin-based agents have been described for weight-regain mitigation. Animal findings are not human outcomes, and the human CBL-0201WR combination trial with tirzepatide had not reported results as of this review.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • Published literature describes CBL-514 as inducing adipocyte apoptosis, with reported DYRK1B inhibition alongside increased caspase-3 and a higher Bax/Bcl-2 ratio. This is the literature-reported mechanism, not a fully settled account.
  • The intended effect is local reduction of fat at the injection site, not appetite or systemic metabolic change.

Safety and unknowns

  • Published trials report safety for the studied populations and durations; the dataset is too limited to establish long-term or uncommon risks.
  • Any injectable that destroys tissue locally requires controlled assessment of injection-site effects; refer to the primary publications for reported adverse events.

Cancer relevance

This section covers questions raised by how the compound works in the body, plus anything regulators and trial teams keep an eye on. It is not a statement that this compound causes cancer — for most compounds here, no human data exist in either direction.

No established human signal

No human cancer effect is established in our record.

Regulatory status

Regulatory decisions apply to specific jurisdictions, products, formulations and indications. An approval elsewhere is not automatically an approval in your country.

Check the regulatory note and linked primary sources for jurisdiction-specific details.

Not approved for marketing anywhere. Caliway reported first patient dosed in the pivotal global Phase 3 SUPREME-01 trial (approximately 320 participants, US and Canada) on 23 September 2026 for large-area abdominal subcutaneous fat reduction. A trial start is not evidence of efficacy.

Evidence grade

L4Good human trialsModerate confidence in rating

Completed, adequately informative controlled human trials supporting a specified outcome; replication and longer-term safety may remain uncertain.

What would change our rating?

  • Peer-reviewed Phase 3 SUPREME-01 results with durability follow-up.
  • Peer-reviewed publication of the Dercum's disease Phase 2 results.
  • Controlled human results from the tirzepatide combination study before any weight-regain claim.

References and sources

Source transparency

A provenance snapshot of this profile. Counts show what kinds of sources are cited, not how much scientific weight each source deserves.

Sources fully curated
Last editorial review
2026-10-03
Recently reviewed · 13 days ago
Linked curated sources
6
Sources still pending
0
External specialist reviews
0
None recorded for this profile
Trial registry: 1Peer-reviewed: 2Sponsor / official: 3

Review provenance

Registry editorial review: Colin Jackson-White, creator and editor, who is not a doctor or clinician. External specialist review is credited only when a named reviewer has completed a review of this exact profile.

Literature-discovery and AI tools may help locate or challenge candidate evidence, but they are not counted as evidence sources here. Registry judgements are tied to the underlying papers, trial records, regulator documents and official study records.

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

These entries record changes to our assessment of the published evidence — not changes to the compound itself.

  1. Added CBL-514, an investigational small-molecule injection (not a peptide), with peer-reviewed Phase 2 and Phase 2b abdominal subcutaneous fat-reduction results, the September 2026 Phase 3 SUPREME-01 start, the tirzepatide combination IND and sponsor-reported Dercum's disease Phase 2 results.

    Change 1 of 1
    L4Good human trials
    Added at L4 for treated-area abdominal fat reduction only, based on completed controlled Phase 2/2b trials. Phase 3 initiation does not raise the grade. Local fat reduction is not obesity treatment; weight-regain and Dercum's findings remain investigational or sponsor-reported. Reviewed 3 October 2026.