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Peptide Evidence Registry

GLP-1s & incretins · Metabolic & endocrine

ASC36_35FDC

A fixed-dose combination of two separate investigational peptides — amylin receptor agonist ASC36 and GLP-1/GIP agonist ASC35 — in Phase 1 for obesity.

L1Theory onlyIn clinical trialsIn clinical development
How settled this rating is:
very-low confidence in the current evidence rating
Routes studied:
Subcutaneous injection
Also known as:
ASC36 + ASC35 fixed-dose combination, co-formulation
Last reviewed:
2026-09-20
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Evidence passport

ASC36_35FDC

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 2026-09-20
Evidence level
L1Theory only
Confidence
Very low confidence in rating
Regulatory status
In clinical trials
Development status
In clinical development

Evidence strength

Human efficacy evidence8 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 evidence8 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 I
Human research maturity
Phase 1 randomised, double-blind, placebo-controlled single and multiple ascending dose study in obesity or overweight with weight-related comorbidities, initiated August 2026 (sponsor-reported); no efficacy results
Source curation
Sources fully curated

Routes recorded

SC injection

Overview

Human efficacy evidence strength8 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 strength35 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 strength8 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.

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: Phase 1 randomised, double-blind, placebo-controlled single and multiple ascending dose study in obesity or overweight with weight-related comorbidities, initiated August 2026 (sponsor-reported); no efficacy results

Routes & formulations

Studied / approved routes

SC injection

A co-formulated injection containing two peptides. Our record does not establish component ratios, and ratios are formulation-specific rather than universal.

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

    Furthest established stage

  4. Phase II

  5. Phase III

  6. Approved

In clinical development

Last documented development: August 2026 — Phase 1 initiation

What it is

Two separate ultra-long-acting peptides in one injection: ASC36, an amylin receptor agonist, and ASC35, a GLP-1 and GIP receptor dual agonist. Because it is two molecules rather than one, it is filed here as a combination, not as a triple agonist.

What people claim

  • Three targets in one monthly injection
  • Beats eloralintide plus tirzepatide

What the evidence actually says

What people claim: that this combination outperforms co-administered eloralintide and tirzepatide. What the evidence actually says: the comparison reported by the sponsor is a diet-induced obese rat study, and the human programme is a Phase 1 safety, tolerability and pharmacokinetics study. Neither establishes human outcomes, and the components' individual evidence does not transfer to the combined injection.

Related evidence

Useful next reads based on this compound — not recommendations.

Human evidence

  • Phase 1, randomised, double-blind, placebo-controlled study of single and multiple ascending doses in adults with obesity (BMI ≥ 30.0) or overweight (BMI ≥ 27.0) with weight-related comorbidities; two formulations with 88 participants each, sponsor-reported, initiated August 2026.
  • No efficacy results have been reported for the combination in people.

Preclinical evidence

  • Sponsor-reported head-to-head diet-induced obese rat study described approximately 51% greater relative body-weight reduction than co-administration of eloralintide and tirzepatide. This is an animal comparison reported by the sponsor.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

Combination of separate drugsTwo or more distinct molecules given together or co-formulated. Evidence for either component alone is not evidence for the combination.

Receptor targets: Amylin receptor, GLP-1 receptor, GIP receptor

Mechanism class counts the receptors the pharmacology engages and says whether one molecule or several drugs do it. More targets is not the same as more effective, and none of these labels is a receptor name — there is no GLP-3, GLP-4 or GLP-5 receptor.

  • Amylin receptor agonism (ASC36) adds satiety signalling outside the incretin pathway.
  • GLP-1 and GIP receptor agonism (ASC35) provides incretin pharmacology.
  • Combining two drugs can combine adverse effects as well as intended effects; that is one of the questions Phase 1 exists to explore.

Safety and unknowns

  • No human safety profile established. Safety and tolerability are the Phase 1 objectives.
  • Combination products require their own safety characterisation; component safety does not transfer.

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

Not established. No human data exist in either direction.

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 anywhere. The sponsor reports US IND clearance and Phase 1 initiation in August 2026. This is a combination of two distinct molecules, so evidence for either component alone is not evidence for the combination.

Evidence grade

L1Theory onlyVery low confidence in rating

Mechanistic rationale or early development without qualifying compound-specific outcome evidence. A registered trial is not a result.

What would change our rating?

  • Posted or published Phase 1 safety and pharmacokinetic results for the combination.
  • A registered Phase 2 trial of the combination with weight endpoints.

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
2026-09-20
Recently reviewed · 26 days ago
Linked curated sources
2
Sources still pending
0
External specialist reviews
0
None recorded for this profile
Sponsor / official: 2

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.

Current linked evidence is sponsor-only. Treat findings as provisional until independent or peer-reviewed documentation is available.

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.

No recorded changes yet. Baseline position set on 2026-09-20.